And very pleased that we have with us at our panel this morning Judge Barron, at the United States District Court, District of Delaware. This case this morning is number 06, 1634, passing in the old Ferreitis Against Biology. This is ETA. Thank you. Good morning. As the court well knows, we're going to have a number of issues. In this case, I think 271, E1 and Section 101 issues are some of the first to that I'll talk about. The reasoning of the District Court as we presented our briefs is that if at any point during the life of a drug, there is any potential reported requirement, then any paths that relate to that drug are cannot be infringed. We think that's a very overbroad reading of 271, E1, safe harbor exception. It's arguably the court that's presented below anything dealing with safety falls under the safe harbor conditions. And that's not what 271, E1, is written. There's every 21 that pertains to pre-approval process for drugs, not post-approval. These are vaccines which were approved a dozen or more years prior to patents being issued and prior to the case, and they might go on back through for another I-N-D-A or A-N-B-A or any sort of approval process. And so 271, E1, we just don't think it applies. On the second one, if it did apply to the activities in the case here, these are clearly researched tool patents, they're not a patent of a compound that you would throw at more, and investigation for efficacy of a compound or how compound could be combined into a drug. But you can't really fit the standard definition of research tools that they can code it, that the national science and the issues adopted. Oh yes, I think you can. How? Where is it fit? It fits under the records. I believe that's in the national standard. You're correct, that something is a way of doing something that can reach the substance of how that shouldn't be treated. Does it automatically turn everything into research tools? Yes, I agree with that. I think there's some. There's some unsolicions in the law, so whatever. So, are you addressing that issue or should we go on to some of the obvious? We're not pressing like this
. I think that that's a secondary issue, it falls under research tools. The primary issue is that 271 is just not applicable to this case, because we're not talking about development of a new drug. We're not talking about activity solely for generating information to support us, the FDA. So I think we'll just outside the scope. So, I'll just say that. 271 is limited to the development of a new drug. It doesn't specify anything about a new drug. It doesn't even specify the FDA in there, right? That's correct. So why should we read these limitations into an otherwise clear statute? Because otherwise the statute applies to all drugs and all patents and all drugs, which dishevees an entire area of the drug. So, how much of a trouble is understanding that argument? How is it that this statute applies to all drugs? If I interpret it the way that the court, the Black Toes suggested should be. Okay, the court in that decision on page 6, paper number 76 on the court, states specifically, Fluid drug administration, black vaccine data, with vaccine manufacturers, active vaccines, and they're approved. Well, that's true for all drugs. The FDA collects data all drugs. The obligation is to report an adverse impact. This unit not to report everything that happens. Correct. It's to report adverse impacts, which all drugs are subject to that. Well, why shouldn't as a matter of statutory interpretation, although I think the legislative history is a really deal with post-registration submissions to the FDA, because, oh, and narrowly, those submissions as I understand, would call the enactment of that statute. They could be many years of pre-registration effort that otherwise was being foreclosed because of the prior statutory interpretations. So if, in fact, an adverse effect on safety, or an efficacy of low-but-end, turns out that's reported to the FDA, why shouldn't that be included? Because it doesn't serve a statutory purpose. The sexual purposes would allow the investigation for generic drugs, so the generic drugs would come on the market, which wants the patents to expire on the brand-name drug. That's the reason that you said 51. E1, and you said when E2, which gives the manufacturer a way to file suit to the general that would be successful
. So would you not agree that the clear language of 271, E1, does not limit to pre- FDA approval activity, but rather the purpose, which we can lean very clearly from the legislative history, suggests that that's what it's supposed to mean. Does that be accurate statement in your heart, argument? If you ignore solely for uses, using your related, because this is a commercial drug that is being sold for commercial purposes, it's being used to treat. It's a vaccine, just be a vaccine. So the purpose is a drug. The statute says solely for uses, reason related to the development of. That's clinical studies, pre-approval clinical studies. So here is a subject, though, it says for submission, for information under A federal law. So where do you get the sense of this statute, the clear language of this statute in some way mandates, it is limited to pre-approval. Because if you're marketing the drug, the drug is not being used solely for. It's being used, reason related to development and submission information. It's being used to treat the vaccinated people. It's being commercial, it's all to make money. It's not. Disactivity isn't just to collect data. That's what a pre clinical, that's what a pre-approval study is. It's for the purposes of the matter, of course, of treating. But the still of the fact that we have a gathering and I hope you say some time to discuss it, doesn't extend all uses of these products, isn't that right? But only to your theory of infringement, to the use which involves the implementation of the studies of optimum application. It's also the subsequent immunization based upon the optimization of vaccine schedules. It's not simply the development of or the recognition of it, not to be scheduled. It's the immunization according to that schedule for the additional treatment of reducing the incidence of...
...the immunization. You mean it? You mean it? That's true, because one of the points that your opponents have made is that they... If in fact they have been applying the vaccine a schedule that experience shows is often a close to it. It couldn't be amplified or patent, couldn't it? Yes, it could. That's the argument that they were already using the same schedule. Yes, it can't because the patent doesn't require that you change the schedule. It doesn't require that you recognize which schedule is correct. And the obligation of it having changed the schedule is inaccurate. These schedules haven't changed and have been modified since the studies were done from four of those schedules to three of those schedules from those schedules to one of the schedules. But the patent doesn't require what you change the schedule, so that you recognize that you make the decision, so it's going to the recognition, to use the schedule that is most popular, either for that patient or that class of the patient or the class of recipients. But if in fact that schedule has already been used, either it would invalid the patent. Or it would be outside the scope of how the registered claims would be. If the patent was if the schedule existed before and was continued to be implemented without reference to the study without consideration of its benefits and treating immune mediated disorders, then that could be true. That particular use, but that particular individual may fall outside the scope. Because I understand Dr. Carson's contribution that was to study the data which have been gathered based on various methods and timing and so on, an immunization to decide which one is optimal. So it would have had to have already been out there in order to be able to study. The schedule of the article cannot be correct, but not the comparison amongst the schedules, the recognition of the effect. Let me ask you, if you don't mind me moving you a little bit, if you're talking about comparison and recognition, these two seem to be mental steps and you acknowledge as much in your brief
. This is not something that has to be done on paper. It doesn't necessarily require clinical trials. So our mental process, patent claims, steps to a subject matter, you're 101. Yes, there is more than a mental process to these claims. Okay, that's a third point. So there's definitely a immunized. And that's not something you're doing in your head. Clearly you're rejecting someone with something or usually. I guess one of them you can now take oral look. But anyway, yes, so clearly you're absolutely right. These are not exclusively mental process claims, but would you agree that the heart from immunizing step and the rest of your patent steps are something that can be done in your head. If we include the immunizing step as the implementation. I'll take a heart from the immunizing step. Say that step wasn't there in the claim. So the rest of that, the steps in your patent claims are things that are not exclusively in your head. You're comparing, you're recognizing, you're thinking about, you're choosing based on your thoughts about which one is better based on the reading materials or schedules. That's all all of those steps of the process are performed in your head. That's correct. And I'm including the implementation of a first schedule as part of the immunization. That's physical. Right, you implement a schedule and we're assuming that. Yes, that's right. You recognize
. That's, I mean that is the implementation of the schedule. Is the immunization according to a schedule? Yes, the rest of it is not required that the actual infringer do the actual clinical study that we read and think about it. But at some point someone has to have done the clinical study to continue the study. That's not what's covered by the claims. It's just the reading about them, the thinking about them and choosing one. It can be covered by the claim if you have to be a person that didn't do clinical study as well. Okay, so, so if you're supposed to have all of those to your claim and I recognize it's not, would that in itself be patentable if the entire every step of your claim is performed exclusively in somebody's head? Now how are we going to police ideas in people's head? How are you going to enforce that? Do you think that covers meant for those sorts of patents to that sort of idea to be patentable? I mean, I don't know. The mental steps and I recognize that's not your patent. So I'm not binding you. What you say with regard to this answer doesn't necessarily bind you in my mind to whether or not it's patentable over 101. I'm just asking you to think about that idea for me. Yes, I think it's clearly patentable subject matter because I don't think a patent statute requires that you are able to enforce your patent in order to have it out. But what about got your suspensives? We just pretty court use the words mental processes are not not a subject matter. They're one of the exceptions like abstract idea, natural phenomena, balls of nature. So, what's the thing that we don't want to disregard that? So, would you would your understanding then be if we're gone by that's a good precedent that says mental processes are not patentable? And if your patent had only been to the first steps, that that would not be patentable. It didn't include any immunizations that. If you have to characterize it as only a mental process, then yes, but I don't think it's just a mental process. So, you should think about something because it doesn't make it only a mental process. Taking into consideration, there's a recognition of certain relationships that were realized by Dr. Cross's in his work, is taking that mental process, if you will, and put it into a therapeutic method of treatment. And so, if the mental process, the result of that, if you take off the immunization step, but as a result of mental process activity, that physician van goes and immunizes somebody according to a checkup. So, let's get rid of that. Even though that immunization step isn't in there, that mental process has resulted in physical action
. We've been really judged as such a matter of according to the claim scope. So, if your claim scope didn't include immunization step, it would be by your own, I think, a mission nothing more than a mental process, right? But it's not your claim, I recognize it. At some point, there are parts that are only mental processes. And so, the part that's not the mental process is the step of immunizing. That's the part that's not. This is up to double thinking about a particular schedule through the immunization process. Through immunization, immunization, particularly, it's not the same black area. So, which the court below recognized was unobvious and not, of course, decision below the death. But they still know that not such to receive such a commitment, I'm trying to come to understand their decision. But that was not a mental process. It was a natural consequence. Well, they used the word mental process in the opinion. They did, but they came to the conclusion that it was a, it was slightly more than a description of the natural process. The correlation to the vaccination and immunization. I think they used all of the exceptions, and to change it, perhaps. But nonetheless, regardless of which exception they characterized it as, they clearly did discuss it at one point as possible. A possible mental process. Right, but the problem with that decision comes into that last step, which is immunization. Because if you take that step out, you're more of all, most of all, methods of treatment become nothing more than, and it's been revealed, mental process of natural phenomena. If you know that, it's a good muscle, that's a natural phenomenon, it has a natural reaction to the body. But you have a pattern of method of treatment, which is natural, so you should be better or worse. So I don't think the court is wrong in that. They ignore it
. This is a method of therapeutic treatment using, if not a natural phenomenon. The Mr. Clausson didn't invent, at least as I understand his claims, a basis for distinguishing the use for which one is best. He says, okay, look at other people's studies, and if they've concluded one has lower risk with your heart and certain side effects, that if these are other things, then another choose that one. That's his contribution. This contribution isn't telling you which one is better. His contribution is, when someone else has shown, for various studies, which one is better, that's the one you should choose. Isn't that right? No, it's not. It's not the accurate because the other studies don't necessarily say one is better or the other. So the study's private, Dr. Clausson. You can't look at studies that occur after Dr. Clausson's contribution and say, oh, that's part of our, Dr. Clausson's contribution is the recognition of relationship. The studies that we conducted, like the finance afterwards, were based upon that recognition. But he doesn't go so far as to say, I have determined, I have recognized, and I think this is why the district court focused on the natural phenomenon. Then he says, I have recognized that this is what we should do and then identify a specific mobility of application, he says, you should do this. Actually, he does. That was another problem with the district court, they looked at one claim from each patent and made a broad-sweeted position on the time of the patent. There are claims that I can pull up. You didn't agree that that claim was represented? No, there was no. There was no oral arguments in the case of the court below, there was no curing, because there were just on the papers. When we argue several times, you can't tell the patent on one claim
. There are 170 or 180 claims, for example, just opening up. Claim 2 of the 139 patents says, a strange schedule is starting less than 42 days after birth. There are specific schedules in here. 8 has a method of treating it goes through a list of different diseases to look for. The first schedule is in the prior act, I realize that we're exhausted your time and you've asked to say so many times. Let's hear from the other side. We'll be sure to stay down and make it clear. The court has focused on the Section 101 issues. That's accepted not to be a middle process because you do physical manipulations. Suppose, however, someone can figure out which other class of compounds is the most effective, just by looking at it and say, how does this have this consistent and this shape and their fluids the best. We want to draw the line in the middle process. Mr. Pleasant doesn't claim to have invented a new schedule, first of all. He has only claimed anything new is in the head of a doctor who does exactly what they did before. He won't be able to say that the first thing that you chose to tell us, which is that this is the middle process. That's what school's out. Then the question becomes, so that's what his invention is. He says that the question is, what happens by appending the physical step of immunizing? Under the Supreme Court President of Fluk, you have to ask yourself, is that a fig leaf? I've been submitted it. You are focusing on the question. I was trying to ask you. I'm sorry. Every invention involves thinking. Somewhere is along the way
. Where do you draw the line between at which one thinks and at which one does, is it? Well, every invention involves thinking to come up with it, but one doesn't claim the thought process of someone else in coming up with something. That's the difference with his claim. He claims what someone else thinks is his invention. He is not claiming a new schedule, a new vaccine, and who will deliver it for example. That distinguishes his invention. As a matter of decision, yes, I agree that that distinguishes it. One of the seniors is, frankly, not true. If you're still talking about statutory subject matter, does it matter who does it thinking? Absolutely, because the claim to a mental process is not patentable subject matter under the Supreme Court President. That's what his claims are, too, because the immunizing step, the only physical step in the claim, is conventional. Obviously, the only logical thing to do that one would do after having a spot process. In fact, that's what one would claim to do in the first place. Any doctor who's going to immunize a baby, then thinks about the class and the work and says, oh, yes, I'll proceed to immunize according to the exact same schedule I've always been using. So you mentioned obviously, obviously, this is a thought process that would have been obvious. It would have been, would not have been obvious. That's a mental evaluation, is it not? I'm not talking about the overall obviousness of the claim when I'm talking about the step, is the logical follow-up. It's the app accordingly step to use Justice Breyer's words after you have looked at the state of the issue. Comparing two schedules for the purpose of determining whether one is safer than the other, whether the one you've long been using is safer, for example. The statute says the invention is a whole, not an individual step on. Absolutely, but the invention as a whole, as he admits, is to thinking that logical step at the end of immunizing or at the beginning, is simply a fig leaf. And the Supreme Court was clear and fluid that you have to analyze it. Just in there, in terms of adjusting the alarm limits, the court held that final step after calculating the alarm limit, the fact that physically going to adjust it did not save the claim, because it would be exalt form over substance. And so the court held that. Let's ask you this question
. Let's say the review of all of the data is Dr. Klasen did. He perceived something, known as notice, he says after two inoculations, 37 minutes apart on the seventh day, are so effective that you don't act on the third. And the third inoculation may be sometimes the right first reactions. Nobody's noticed that before. What happens to that insight? What happens to that contribution? But what he didn't do is claim that particular schedule. And only the independent claims are an issue, which I can address with the court. He never argued that Judge Horl's for example, did they do it? I don't know what the third would be, but anyway, of claiming such an observation. You absolutely might be able to claim a new schedule, for example. Somebody hadn't done it before. You thought of it, and you say, oh, I'm going to claim this schedule with this particular vaccine at three months, four months, ten months. Perhaps you might well be able to claim that, but that's not what these claims are about. So, it has, well, you think that sort of mental processes are not that well-discord precedent. I mentioned, Godchalk, the Benson. Is there anything else that you think was credibility for that notion? Because arguably, the statement of Godchalk, the Benson was stictored, right? I mean, it wasn't a mental process in that case. Well, it's true in terms of a case where a claim was, for example, only to a mental process, other than perhaps the last four cases. I'm not sure, but certainly those claims, Benson, Fluke, they covered, I would submit a mental process. If you could carry out those mathematical calculations in your head, that would be an aspect of the claim, as here. So, as he admitted, you might conduct a physical study, but you also would be thinking in your head about somebody else's state. So, your saying that you believe Fluke was a mental process claim? Well, the only physical step in it was to adjust the alarm limits at the end, and what was involved up to that point was calculating. And so to be clear, I am pretty sure that the president dramatically diminished the impact of Benson due to not being a long software industry space on that evolution. Well, that's a very difficult comparison by itself, thanks to strong statements of the time that it is disaggregated. But I would submit that no precedent has cut back on the very old idea and basic idea that mental process is not palatable. In the dire include cases, it's true that the court was addressing computer algorithms, as well as this court has subsequently addressed in a variety of cases. But that's not what this case is, there is no algorithm in Mr. Classin's claims. And if I responded to court, I'd like to turn to the inherent anticipation point, because before you go there, so would you suggest that a mental process claim of the claim was written to a machine performing a process, which would just so happen that process could also be performed in your head, but the claim was in fact a machine claim. You wouldn't suggest that's unpatatable under the mental process exception, would you? Well, again, as you influte, you've got to look at what was invented, and it's true that in some instance you might attach a machine to it, and then we get back into all the line of cases that ask what you've gotten, but you have to ask what the inventor has invented. Look, I mean, I don't know if you're thinking the same way I am, but your statement can suggest to be that all software is now unpatatable, if we rule that this case a mental process is unpatatable. Because my concern is, I'm not going to go too far. No, and I'm worried about creating a slippery slope here. If I say mental processes are unpatatable, is the result of that that if you pull well if you put a mental process on a machine, I mean software and allocatines plus function type points or state tree, these function type claims, how about we just render them unpatable all those things, because I can't do that. Now, I'm not submitting that algorithms are unpatable subject matter at all. We don't even have to address that because he has no algorithm. He has a straight up, read somebody's paper, reach a mental conclusion through no process that he tells you how to derive the hack. You can reach that even if you read papers that reach the contrary conclusion, and he doesn't tell you why you would dismiss all of the studies of the FDA, the staff and the shared all the people who say that his conclusions are unfounded. And I apologize if I confused the court in making a suggestion that any of the cases in discussing algorithm, there are necessarily mental process cases. That is not my position. So now you're saying fluke is not a mental process the way this case is a mental process. Fluke is a mechanical algorithm. Well, I don't involve the facts of fluke claim in mind. It was a calculation for adjusting an alarm limit. My recollection was that it was a fairly simple calculation. And I don't think that the claim was tied to something physical other than adjusting the alarm limit at the end. But clearly the reason that you don't want an inter-mental process claims so often I would sit in this because it's so clearly unpatentable that in general they're not getting through the process. So in the case why didn't you reach that point? Well, we would submit a chin-f
. In the dire include cases, it's true that the court was addressing computer algorithms, as well as this court has subsequently addressed in a variety of cases. But that's not what this case is, there is no algorithm in Mr. Classin's claims. And if I responded to court, I'd like to turn to the inherent anticipation point, because before you go there, so would you suggest that a mental process claim of the claim was written to a machine performing a process, which would just so happen that process could also be performed in your head, but the claim was in fact a machine claim. You wouldn't suggest that's unpatatable under the mental process exception, would you? Well, again, as you influte, you've got to look at what was invented, and it's true that in some instance you might attach a machine to it, and then we get back into all the line of cases that ask what you've gotten, but you have to ask what the inventor has invented. Look, I mean, I don't know if you're thinking the same way I am, but your statement can suggest to be that all software is now unpatatable, if we rule that this case a mental process is unpatatable. Because my concern is, I'm not going to go too far. No, and I'm worried about creating a slippery slope here. If I say mental processes are unpatatable, is the result of that that if you pull well if you put a mental process on a machine, I mean software and allocatines plus function type points or state tree, these function type claims, how about we just render them unpatable all those things, because I can't do that. Now, I'm not submitting that algorithms are unpatable subject matter at all. We don't even have to address that because he has no algorithm. He has a straight up, read somebody's paper, reach a mental conclusion through no process that he tells you how to derive the hack. You can reach that even if you read papers that reach the contrary conclusion, and he doesn't tell you why you would dismiss all of the studies of the FDA, the staff and the shared all the people who say that his conclusions are unfounded. And I apologize if I confused the court in making a suggestion that any of the cases in discussing algorithm, there are necessarily mental process cases. That is not my position. So now you're saying fluke is not a mental process the way this case is a mental process. Fluke is a mechanical algorithm. Well, I don't involve the facts of fluke claim in mind. It was a calculation for adjusting an alarm limit. My recollection was that it was a fairly simple calculation. And I don't think that the claim was tied to something physical other than adjusting the alarm limit at the end. But clearly the reason that you don't want an inter-mental process claims so often I would sit in this because it's so clearly unpatentable that in general they're not getting through the process. So in the case why didn't you reach that point? Well, we would submit a chin-f. How does the idea of clinical discretion of the physician assist you in your argument about the mental processes of this plan? Well, he doesn't give any means for solving the dilemma for example if you're faced with conflicting data. And he says at 827 in a declaration of his that there's data that you can inferring or you can immunize early or you can immunize later in the one case you're lowering the risk of diabetes and the other case you're lowering the risk of asthma. And he doesn't tell you how to resolve that. So that's an aspect. No, not already archimedism as opposed to the signs of medicine. And isn't that why it's the exercise of mental process that you strive for? Right. It's the exercise of mental process in which he gives no guidelines for how long should carry that out. So if I might because I'm running into my book Council's time, I would just like to emphasize that alternatively if one focuses on the physical step now, the immunizing step, there's no question that that is old he admits it. You can immunize it with the same old ACI piece scheduled from the late 1980s. So then all you left with in his claims is the recognition of what is an inherent property and it's well established under the Bristol Myers case under the in-registered sprowth case, which slides the in-ray-may case, all of those cases, his claims are inherently anticipated. Finding I would just like to make clear with respect to the dependent claims, he never argued to the court below that the court should look at limitations of the dependent claims. He took his broad construction for purposes of infringement. We then used that both to get some adjustment on non-imferentions, we took his claim instruction. We then took his claim instruction on invalidity, was lived by the sword, died by the sword. If he was going to raise limitations as being relevant, for example, as he did today, under Conoco, he had to raise them below the doctrine of waiver of a stockman appeal, he can't raise them now. Finding with respect to non-imprintment so that the record is clear, I would just like to point out that there were only four documents before the district court that were considered on the motion for some rejuvenation and that should be considered on the motion for some rejuvenation. Those were the DeSepthano study, Placins letter, and the DeSepthano response, the more package instur, and the FDA response. All of the other material, the East Side, the Asherio study, any other studies all came in at the earliest on the motion for reconsideration and the Judge property health that he had given no reason not to have cited those earlier. I understand that you are wondering, with that in mind, I will turn it to the Court please to the 271 E issue. Let me say that the outset that we recognize that the precise question that we posed to Judge Quarles and in which he ruled in our favor has not been considered by this Court, or by the Supreme Court, that is to say whether or not the 271 E1 exemption can apply to post-approval activities. We submit, however, that under the Supreme Court's decision in Murk versus Integra and the plain language of the statute that that is the conclusion. But it was an issue in Murk, it's not really quite appropriate in the Supreme Court to read a decision on quite limited facts that the Court did. I know what I did, it might be effective
. How does the idea of clinical discretion of the physician assist you in your argument about the mental processes of this plan? Well, he doesn't give any means for solving the dilemma for example if you're faced with conflicting data. And he says at 827 in a declaration of his that there's data that you can inferring or you can immunize early or you can immunize later in the one case you're lowering the risk of diabetes and the other case you're lowering the risk of asthma. And he doesn't tell you how to resolve that. So that's an aspect. No, not already archimedism as opposed to the signs of medicine. And isn't that why it's the exercise of mental process that you strive for? Right. It's the exercise of mental process in which he gives no guidelines for how long should carry that out. So if I might because I'm running into my book Council's time, I would just like to emphasize that alternatively if one focuses on the physical step now, the immunizing step, there's no question that that is old he admits it. You can immunize it with the same old ACI piece scheduled from the late 1980s. So then all you left with in his claims is the recognition of what is an inherent property and it's well established under the Bristol Myers case under the in-registered sprowth case, which slides the in-ray-may case, all of those cases, his claims are inherently anticipated. Finding I would just like to make clear with respect to the dependent claims, he never argued to the court below that the court should look at limitations of the dependent claims. He took his broad construction for purposes of infringement. We then used that both to get some adjustment on non-imferentions, we took his claim instruction. We then took his claim instruction on invalidity, was lived by the sword, died by the sword. If he was going to raise limitations as being relevant, for example, as he did today, under Conoco, he had to raise them below the doctrine of waiver of a stockman appeal, he can't raise them now. Finding with respect to non-imprintment so that the record is clear, I would just like to point out that there were only four documents before the district court that were considered on the motion for some rejuvenation and that should be considered on the motion for some rejuvenation. Those were the DeSepthano study, Placins letter, and the DeSepthano response, the more package instur, and the FDA response. All of the other material, the East Side, the Asherio study, any other studies all came in at the earliest on the motion for reconsideration and the Judge property health that he had given no reason not to have cited those earlier. I understand that you are wondering, with that in mind, I will turn it to the Court please to the 271 E issue. Let me say that the outset that we recognize that the precise question that we posed to Judge Quarles and in which he ruled in our favor has not been considered by this Court, or by the Supreme Court, that is to say whether or not the 271 E1 exemption can apply to post-approval activities. We submit, however, that under the Supreme Court's decision in Murk versus Integra and the plain language of the statute that that is the conclusion. But it was an issue in Murk, it's not really quite appropriate in the Supreme Court to read a decision on quite limited facts that the Court did. I know what I did, it might be effective. You mean the District Court, Gaurna? No, the Supreme Court, you were saying that we read the broad language and in Integra it did indeed that grant reach some of the facts that were presented in that case. Yes. But this post-registration set of submissions to the FDA for whatever reason, certainly not to obtain registration, is it close to that situation? No, it's not the precise situation was before the Court. But as I think I obligated to do as any advocate before this Court, is that when you're confronted with case of first repression, the question has never been flooded before, I think it's appropriate to look at what has been said by a prior court's four guidance. But let's focus on what I could run on the statute, which I think gives us the answer. 271 bias express terms is not limited to pre-approved versus post-approval activities. And the exemption says, don't look to time I may take. There's nothing of the statute that says, look at the time. What the statute says is look at the activities that is engaged in by the defendant to the extent is alleged to have used an infringing product or an infringing process. And ask yourself. It was to go back in time, not to go fooling in time. A bit there was substantial debate in terms of going back in time, in that case to move the law basic, if I can use that to research. But in terms of going over it in time after a problem just initial, it wasn't before the Court. I understand that. So we have to decide on how we reach or how it should reason to answer the question we've posited. And we conclude that since the statute taking the statutory language at its face, it provides an exemption for use of patented inventions or processes, patented processes, reasonably related to information and data that one must submit. Hold on though, you just read out the word solely. I mean, you know, counsel before you point out that the patent exempts act solely for uses, reasonably related to the development of submission of information under federal law. When you're using a particular method and commercial met commercial process or using it commercially, did that solely for uses or submitting to the FDA? Judge Moore first of all, in my response to the question of how to use it with solely, I will adopt what the Supreme Court has said. And that is that they do not, as I read Justice Scalia's decision, and other cases that have decided this, they don't read solely to me that the only purpose for which the work is done is to gain FDA approval. It's clear from that, from Merck, as well as cases in this Court, that there can be many other purposes for reasons that flow from the statute. The focal point should be at the time we practice, if at all, and we don't say that we did, but on 12 B6, I assume the truth of the allegations is clear. At the time, the class and method was practiced, which is to compare immunization schedules and decide whether or not one is more risky, arrogant, adverst
. You mean the District Court, Gaurna? No, the Supreme Court, you were saying that we read the broad language and in Integra it did indeed that grant reach some of the facts that were presented in that case. Yes. But this post-registration set of submissions to the FDA for whatever reason, certainly not to obtain registration, is it close to that situation? No, it's not the precise situation was before the Court. But as I think I obligated to do as any advocate before this Court, is that when you're confronted with case of first repression, the question has never been flooded before, I think it's appropriate to look at what has been said by a prior court's four guidance. But let's focus on what I could run on the statute, which I think gives us the answer. 271 bias express terms is not limited to pre-approved versus post-approval activities. And the exemption says, don't look to time I may take. There's nothing of the statute that says, look at the time. What the statute says is look at the activities that is engaged in by the defendant to the extent is alleged to have used an infringing product or an infringing process. And ask yourself. It was to go back in time, not to go fooling in time. A bit there was substantial debate in terms of going back in time, in that case to move the law basic, if I can use that to research. But in terms of going over it in time after a problem just initial, it wasn't before the Court. I understand that. So we have to decide on how we reach or how it should reason to answer the question we've posited. And we conclude that since the statute taking the statutory language at its face, it provides an exemption for use of patented inventions or processes, patented processes, reasonably related to information and data that one must submit. Hold on though, you just read out the word solely. I mean, you know, counsel before you point out that the patent exempts act solely for uses, reasonably related to the development of submission of information under federal law. When you're using a particular method and commercial met commercial process or using it commercially, did that solely for uses or submitting to the FDA? Judge Moore first of all, in my response to the question of how to use it with solely, I will adopt what the Supreme Court has said. And that is that they do not, as I read Justice Scalia's decision, and other cases that have decided this, they don't read solely to me that the only purpose for which the work is done is to gain FDA approval. It's clear from that, from Merck, as well as cases in this Court, that there can be many other purposes for reasons that flow from the statute. The focal point should be at the time we practice, if at all, and we don't say that we did, but on 12 B6, I assume the truth of the allegations is clear. At the time, the class and method was practiced, which is to compare immunization schedules and decide whether or not one is more risky, arrogant, adverst. And then, of course, do we have an obligation to report that to the FDA? And the answer under the regulations and the statute is clear, we must. And what we're arguing to this Court, an artificial barrier of pre-approved post-approval should not make a difference. Let me give you a concrete example. Let us assume as we were petitioning the FDA for approval of a vaccine, that we found that if you gave the vaccine at two months instead of four months, at two months, 50% of the children in the United States got diabetes. If we gave it four months, two percent. The FDA on questionably would want to know that data, and class and even admits that if we gave that data of adverse events based on a study in a comparison, pre-approval, 271 exempts our identities. Now, let's assume in my example that nine days after approval, a new study comes out, which reports for the first time, that if you also give the vaccine at six months, 100% of the children of America will contract diabetes. Under the class of theory, even though we are required by federal regulation to report those adverse events, to do so would subject us to compensatory and potentially triple damages for patent and free time. Not to report them to the, to perform the patent and the methods of actually to damages from a stranger, not to do the reporting. The reporting is required to do by law having the data in comparison, is what suggests you damage it. Right, what I'm saying is 270, you're right, how do we get the data? And what I'm saying is 271 be one, gives, we believe, a safe harbor to activities that are performed whenever they're performed, as long as they're reasonable or related to submission of data that is required by the FDA. And while I agree to judgment, the Supreme Court has some very broad language in more versus in particular, and all they were looking at was whether or not preclinical data is subject to the exemption, not just clinical data. I do have to rely on, I think, Justice Scalia was attempting to give us some guidance as the Court was on 271 when they said that the exemption extends to all uses of patent and inventions that are reasonably related to the development and submission of any information under the FDA. Now, the Court could have qualified a language. The Court was on the same, there's simply no room in the statute for excluding certain information from the exemption on the basis of the phase of the research in which it was developed or the particular submission in which it could be included. Yes, would you go very well in which phase of research that was directed to? I understand, but let me. And also in terms of your argument, there even being that class and class, their broadest interpretation, you can say that obtaining the data of measuring the effect of timing on the infant or whatever. I would not have shown how to interpret the patent, but I think that even in the broadest interpretation, the read is not saying that there's an infringement in obtaining that data, whereas in the American temperate case, it was the obtained doing research that was auditioned. I understand, you know, in this case, you know, the only reason we, if we practice the claimed method of class, which is to compare vaccination schedules to determine which one is more or less risky, in other words, to look for either adverse events, fortifying that there are no adverse events, that we may have came to that process, that is reasonably related to what we have to submit to the FDA. Let me just add, you know, one would be late and let's say in the United States, because it's not that it says in three to six pages of obtaining the data and filing with the FDA. He says using afterwards is something that he has talked, how would you? Well, you wondered, the courts have answered that if there is some subsequent use of data, whether it's pre-approval or post-approval, that results, nevertheless from activity that pharmaceutical company engages in, because it's reasonably related to requirements under the FDA or under any federal statute, that doesn't take us out of the safe harbor. The court has said there may be collateral for additional uses to the data. Our point is, is it
. And then, of course, do we have an obligation to report that to the FDA? And the answer under the regulations and the statute is clear, we must. And what we're arguing to this Court, an artificial barrier of pre-approved post-approval should not make a difference. Let me give you a concrete example. Let us assume as we were petitioning the FDA for approval of a vaccine, that we found that if you gave the vaccine at two months instead of four months, at two months, 50% of the children in the United States got diabetes. If we gave it four months, two percent. The FDA on questionably would want to know that data, and class and even admits that if we gave that data of adverse events based on a study in a comparison, pre-approval, 271 exempts our identities. Now, let's assume in my example that nine days after approval, a new study comes out, which reports for the first time, that if you also give the vaccine at six months, 100% of the children of America will contract diabetes. Under the class of theory, even though we are required by federal regulation to report those adverse events, to do so would subject us to compensatory and potentially triple damages for patent and free time. Not to report them to the, to perform the patent and the methods of actually to damages from a stranger, not to do the reporting. The reporting is required to do by law having the data in comparison, is what suggests you damage it. Right, what I'm saying is 270, you're right, how do we get the data? And what I'm saying is 271 be one, gives, we believe, a safe harbor to activities that are performed whenever they're performed, as long as they're reasonable or related to submission of data that is required by the FDA. And while I agree to judgment, the Supreme Court has some very broad language in more versus in particular, and all they were looking at was whether or not preclinical data is subject to the exemption, not just clinical data. I do have to rely on, I think, Justice Scalia was attempting to give us some guidance as the Court was on 271 when they said that the exemption extends to all uses of patent and inventions that are reasonably related to the development and submission of any information under the FDA. Now, the Court could have qualified a language. The Court was on the same, there's simply no room in the statute for excluding certain information from the exemption on the basis of the phase of the research in which it was developed or the particular submission in which it could be included. Yes, would you go very well in which phase of research that was directed to? I understand, but let me. And also in terms of your argument, there even being that class and class, their broadest interpretation, you can say that obtaining the data of measuring the effect of timing on the infant or whatever. I would not have shown how to interpret the patent, but I think that even in the broadest interpretation, the read is not saying that there's an infringement in obtaining that data, whereas in the American temperate case, it was the obtained doing research that was auditioned. I understand, you know, in this case, you know, the only reason we, if we practice the claimed method of class, which is to compare vaccination schedules to determine which one is more or less risky, in other words, to look for either adverse events, fortifying that there are no adverse events, that we may have came to that process, that is reasonably related to what we have to submit to the FDA. Let me just add, you know, one would be late and let's say in the United States, because it's not that it says in three to six pages of obtaining the data and filing with the FDA. He says using afterwards is something that he has talked, how would you? Well, you wondered, the courts have answered that if there is some subsequent use of data, whether it's pre-approval or post-approval, that results, nevertheless from activity that pharmaceutical company engages in, because it's reasonably related to requirements under the FDA or under any federal statute, that doesn't take us out of the safe harbor. The court has said there may be collateral for additional uses to the data. Our point is, is it... Do you really have to stretch your analysis of the safe harbor, this far? Do you have to do make the point? Perhaps not as far. Our point simply is that the report that the practicing is patterned, if done, is for the purpose of determining whether or not there's adverse. He's not attacking the reporting. He's attacking the subsequent use that, as I had indicated, which would be infringed only by the physicians, he says, all right, and by the medical office, this is the schedule I'm going to use for administration that has vaccines. And I gather that all the reason that these entities are the defendants is because of their instructions that come to the vaccine. That is a continuity to the infringement. Portably according to his allegations, that's what we understand, the big however, that I think you picked right on the head. What he has to be focused on is the work that was done by the pharmaceutical company. And if his method is used, we're saying that was used to report data to the FDA. And that's why we don't accept and our system is not to accept a pre-approval versus a post-approval line. Imagine that, that shouldn't be, we maintain the focal point of the analysis. We were able to retire from the medical issues, but you've got this. The questions you've asked. Thank you. Thank you. Mr. Senior, what's the emergency emergency? Mr. Senior, it's time to wipe the battery ran over the physical after-mits. Okay. Thank you. Thank you
... Do you really have to stretch your analysis of the safe harbor, this far? Do you have to do make the point? Perhaps not as far. Our point simply is that the report that the practicing is patterned, if done, is for the purpose of determining whether or not there's adverse. He's not attacking the reporting. He's attacking the subsequent use that, as I had indicated, which would be infringed only by the physicians, he says, all right, and by the medical office, this is the schedule I'm going to use for administration that has vaccines. And I gather that all the reason that these entities are the defendants is because of their instructions that come to the vaccine. That is a continuity to the infringement. Portably according to his allegations, that's what we understand, the big however, that I think you picked right on the head. What he has to be focused on is the work that was done by the pharmaceutical company. And if his method is used, we're saying that was used to report data to the FDA. And that's why we don't accept and our system is not to accept a pre-approval versus a post-approval line. Imagine that, that shouldn't be, we maintain the focal point of the analysis. We were able to retire from the medical issues, but you've got this. The questions you've asked. Thank you. Thank you. Mr. Senior, what's the emergency emergency? Mr. Senior, it's time to wipe the battery ran over the physical after-mits. Okay. Thank you. Thank you. When we first addressed the last two-something-one issue, what defense counsel's trying to do is extend 271 to a safety statute. The statute has nothing to do with safety. It's good that if you find something to be adverse that you have to report it to the FDA. But 271, he won't apply to that, doesn't protect that. And as we talked about, he'll talk about the FDA. So to say that extension, anything that has to do with safety that requires an report with, with, with this year of all patents associated with that, you know, I don't know. Things come like airbags are safety related. Whether they deploy or don't deploy requires or report you to some kind of agency from the Department of Transportation. Well, according to this theory, if there's some safety issue and you have to do some report patents in that area no longer apply. That's just not correct. Counsel, before you knew on, should, counsel for defense argued that you never argued below the court needs to look at the heat and the claim limitations. And in particular, when you read the data, about 42 days and all of that. That's completely correct. Can you tell me where in the record I will find evidence that you made this argument below? It was it in particular briefs? Was it the argument? I'm not sure you get everything. I can look at all of it. So you just tell me where I'll find it. I can't want to exact dependence page. But in the, you say it's definitely the one that's used to mint here. I don't think it's in the appendix because it is a race issue earlier. So if it came, can you provide it to us? So, gentlemen, counsel, the other side, in the human file reference, just write it in a sentence. So I can tell you where it is now. I'm going to ask for a file in response to Judge Moore's question that will say this. So, let me, Mr
. When we first addressed the last two-something-one issue, what defense counsel's trying to do is extend 271 to a safety statute. The statute has nothing to do with safety. It's good that if you find something to be adverse that you have to report it to the FDA. But 271, he won't apply to that, doesn't protect that. And as we talked about, he'll talk about the FDA. So to say that extension, anything that has to do with safety that requires an report with, with, with this year of all patents associated with that, you know, I don't know. Things come like airbags are safety related. Whether they deploy or don't deploy requires or report you to some kind of agency from the Department of Transportation. Well, according to this theory, if there's some safety issue and you have to do some report patents in that area no longer apply. That's just not correct. Counsel, before you knew on, should, counsel for defense argued that you never argued below the court needs to look at the heat and the claim limitations. And in particular, when you read the data, about 42 days and all of that. That's completely correct. Can you tell me where in the record I will find evidence that you made this argument below? It was it in particular briefs? Was it the argument? I'm not sure you get everything. I can look at all of it. So you just tell me where I'll find it. I can't want to exact dependence page. But in the, you say it's definitely the one that's used to mint here. I don't think it's in the appendix because it is a race issue earlier. So if it came, can you provide it to us? So, gentlemen, counsel, the other side, in the human file reference, just write it in a sentence. So I can tell you where it is now. I'm going to ask for a file in response to Judge Moore's question that will say this. So, let me, Mr. Taylor, it's in the brief. The first thing that I'm going to say to the counsel before you write to him is that we don't have an argument about which is in it. That's great. Just fine. Just fine. So, in the briefing, one of the motions for some of you at the first file, we are into the court. There's been no claim construction. How can you determine the infringement or not infringement without a claim construction? And we submitted a chart showing that there was no construction. All the claims, not just the product that initially, we asked a reconsideration based upon the fact that there was a some rejection of not infringement without it returperated what the claims mean or don't mean. So we raise an issue vigorously. Well, all of what you present, but it seems to be that could be a different issue than whether or not you separately raised that the kind of claim should be treated differently. No, we raised it, you can. Just give us the other question. We talked about the opinion claims. Okay. And you say, the answer is question. And addressing the mental process issue, which was addressed by Council for Merck. Council for Merck wants to free out any novelty of the mental processes, which are part of a lot of pack claims. And then just say immunization. Merck's argument is twofold. One that this is just another process plan. It's not just another process plan. Like Deer, which has the switching at the time
. Taylor, it's in the brief. The first thing that I'm going to say to the counsel before you write to him is that we don't have an argument about which is in it. That's great. Just fine. Just fine. So, in the briefing, one of the motions for some of you at the first file, we are into the court. There's been no claim construction. How can you determine the infringement or not infringement without a claim construction? And we submitted a chart showing that there was no construction. All the claims, not just the product that initially, we asked a reconsideration based upon the fact that there was a some rejection of not infringement without it returperated what the claims mean or don't mean. So we raise an issue vigorously. Well, all of what you present, but it seems to be that could be a different issue than whether or not you separately raised that the kind of claim should be treated differently. No, we raised it, you can. Just give us the other question. We talked about the opinion claims. Okay. And you say, the answer is question. And addressing the mental process issue, which was addressed by Council for Merck. Council for Merck wants to free out any novelty of the mental processes, which are part of a lot of pack claims. And then just say immunization. Merck's argument is twofold. One that this is just another process plan. It's not just another process plan. Like Deer, which has the switching at the time. Then you don't, you ignore the amount of process and don't look at that as part of the claims of all. Whereas all the cases all these side of that are brief. So as you look at all the elements, you look at the mental process on the mental process. And there's a whole to the trouble whether it has statutory subject matter, whether it has novelty and the obviousness. We submit it to the mental. The parts of the claims that can be done by the force and not be done by the way show the invention that's there. And for aspects of the claim. Merck's argument wants to rate those out. So say since they're mental processes. I definitely didn't understand what you're saying. And I recognize the problem that you find with it. What about the fact that I think she may also argue that it's insignificant activity that just tacking on vaccination, immunizing someone according to what is more. I mean, literally people with vaccinated for a long time. So the immunizing part of this whole process isn't the novelty of invention. But I don't want to confuse concepts. So I think that what she might have also been saying is tacking on a little bit of physical step to what is clearly just a mental process isn't enough to overcome fluke and deer. And she pointed to fluke where they said, you know, fig leaf. You know, it's sort of big whatever. Whatever the language was. But tacking on an insignificant post-solution or pre-solution activity isn't enough. So tell me how you would respond to that. It's not an insignificant post-solution activity because you're immunizing. It's a method of treatment immunizing to reduce and you immediately disorders that is only recognized by what we're now calling the mental process steps
. Then you don't, you ignore the amount of process and don't look at that as part of the claims of all. Whereas all the cases all these side of that are brief. So as you look at all the elements, you look at the mental process on the mental process. And there's a whole to the trouble whether it has statutory subject matter, whether it has novelty and the obviousness. We submit it to the mental. The parts of the claims that can be done by the force and not be done by the way show the invention that's there. And for aspects of the claim. Merck's argument wants to rate those out. So say since they're mental processes. I definitely didn't understand what you're saying. And I recognize the problem that you find with it. What about the fact that I think she may also argue that it's insignificant activity that just tacking on vaccination, immunizing someone according to what is more. I mean, literally people with vaccinated for a long time. So the immunizing part of this whole process isn't the novelty of invention. But I don't want to confuse concepts. So I think that what she might have also been saying is tacking on a little bit of physical step to what is clearly just a mental process isn't enough to overcome fluke and deer. And she pointed to fluke where they said, you know, fig leaf. You know, it's sort of big whatever. Whatever the language was. But tacking on an insignificant post-solution or pre-solution activity isn't enough. So tell me how you would respond to that. It's not an insignificant post-solution activity because you're immunizing. It's a method of treatment immunizing to reduce and you immediately disorders that is only recognized by what we're now calling the mental process steps. So it's not the word immunizing is trivial. But why are you immunizing? How are you immunizing? You know, immunizing is based on what the schedule select is. It's not true of steps. It's a very, very important step. It saves lives. It's that important step. In fluke, recognizing that something was too high or too cold, there's a kind of mental process which is the extrusion too high or too cold, changes time. The mental process itself was trivial and a solution, the implementation was trivial. The mental process is far from trivial and again I'm calling it a process for the sake of argument here. Because it is the recognition of not only something that was never recognized but something that was taught against in the prior art as you heard. The findings of argument in this case they still don't believe that the distribution of Dr. Cross is as found and that it's a step no support. Actually, some damn shagas even though they say they don't, there's still some argument about that. So it's important and that's why I'm saying you can't divorce the mental steps from the non mental steps. It's like, oh look, that non mental step is trivial. If that non mental step is based upon the significant amount of the lower court found, non obvious and novel mental rights. The lower court found that it's not a prior art. I didn't see that. Did they, is there a trial of mental, somewhere or an incident or a trial of mental? Of course, the decision. They said the defendants have not raised, have not shown any evidence where any of this is not correct. I don't know. I have much more value. Okay, I'll tell you
. It's in the trial of course