and effective and so the problem with the f d a is interpretation is they gave it a broader meaning and allowed such drug to encompass both at the same time for purposes of approval but the statute here is that the following applications has a choice and if they choose to roll law by all of the studies of the pioneer out then under the major show conditions of approval of such a drug if you compare that structure to the structure of the patent certification where someone is certifying to patterns which claim a use for such terms of not necessarily equating those to the of such drugs being in the propositional phrase or if such drug is operative there that it can be interpreted more narrowly then the way that such a drug would be interpreted for purposes of patents or occasion and for purposes of getting approval in the first place when you say such drug not not for purposes of pan certification let's get the argument that you know we did look for consistency across different provisions but if we focus on the provision that's more directly an issue here the such a drug which drug are you talking about the this such drug and that refers back to the considered made to show whether the follow on applications is approved well in the last part of the not quite understand so it seems like you're presupposing that there is some relationship between the two drugs in other words it's not entire it's not an entirely unmoored inquiry into conditions of approval it's not the case that if if one gets approval for a headache drug then any other drug no matter how distinct that has to do with headaches is off limits that the exclusivity attaches to even as to that right so there are some relationship between the drug for which approval had been had already been obtained and as to which excludes exclusivity attaches and the drug that we're talking about now that's asserted to be out of bounds still clear and unambiguous interpretation here which arises from this such as even if you're going to give operative a fact that then you have to be giving a fact that consistent across all these and what's the relationship between those two drugs because what that the agency says is the relationship is active noisy and if it's not a circumstance of active moiety then we're not worried about exclusivity at that point but we can because we're talking about something different and as i understand your position you of course don't agree that it's active moiety on the issue that you think that in fact you think that reading is prohibited by the statute but you also don't agree that that no association between the drugs would still be ok there's got to be some kind of chemicals that is the is the association that makes that close enough that you can rely on the pioneer to get approval so any time or any time you rely on the initial drug the first time drug whatever literature you can also rely on i thought this was an interesting example brought up on the other side i think a lot of it by the interviewer but you can rely on in active ingredient so you have something you wrote it makes all the sense in the world to rely on an active  ingredient because he was a look there's been a bunch of stuff that shows that the in active ingredient doesn't pose any safety issue so we're fine as far as that goes so don't don't worry about that wouldn't have anything to do with the helpful qualities of the thing for which we're seeking to get approval it's just  ingredient as opposed to treating that there's a line that you draw in terms of when you are relying on previous studies between reliance on something that's in the waiter or approved application that that's ti the background principles now to the extent that something is subject to x use of it in the sense that someone did a clinical study that clinical study was part of their drug then i think you could say that they are equating the two even though it is the greedy and i just think it's a far fresh hypothetical in reality because people will easily find ways around this then then they would be equating the two would have to accept yes now that question of course is not before this because here we have a very tight connection in the sense that we have a right that we're just trying to understand the implications of your position and i guess the implications of your position is that any time even though congress clearly wanted to create a regime under which the alliance was promoted in order to streamline the approval process your position is when you say take the bitter with the to figure out a way to do it without rely right if if you have magic that stringent requirements to got next to seventy which means it has to be essential for approval so if there was background literature that predated the pioneers application that related to that in active ingredient then it's going to be very difficult for the pioneer to have any exclusivity that that is actually covering but yes once they do this in the end because i think the rational purpose was to balance these two provisions in the sense that they wanted to streamline they wanted people to be able to rely on what came before but under certain circumstances and those circumstances mean because it's just the conditions of approval and the change is is for an error and more targeted and in particular in this world it gives you a lot less protection against off label use in the sense that you marginal innovation what have you adding what is the change that you have made and it's not focusing on what has remained the same weight and i take it that it is common ground in this case as fish from us and pointed out that to determine the conditions of approval of a drug why are some kind of comparison between the two drugs  and the idea is way of making that comparison is indeed reasonable and in accordance with longstanding agency policy and i would stress in particular this court's decision in activists which addressed this question in a somewhat different context but i think goes a long way towards saying that the f b i reasonably resolved the question for the court i mean in activist the question was whether one drug that is a pro drug  progress or at least that's your position to get you longer there's like a pro drugs and the permissibility of using active moiety at least in that context i take it the to this position is that's all fine and dandy but what we're talking about here a reliance and once you rely on a study with respect to a particular drug well you're relying on that drug to show that your drugs ok if you rely on that you're subject to the exclusivity for that drug on which you rely and if you don't want to deal with a society they don't pathway reliance in the sense in which that's appropriate is a different sense then whether two drugs are the same and the reason for that is because look as i think your honor pointed out i mean you can rely on a dr agency document that talks about a number of different examples where they relied upon drug maybe significantly different i mean for example the u s army got approval of a drug to treat nerve gas poisoning i guess on the basis of statutory structure but when you examine the statutory structure i think it becomes clear that congress is using the term drug in a variety of of different senses i mean the b two pathway at the front of the satcher the refers to referring to they relied upon drugs which in this case would be a bill of five tablets in the patent noticed provision the drug being referred to is once again the applied for drug here aristotle and then fast forwarding structural reading of the sadness really saturate in context and in structure only underscores that we've acted reasonably here i'm trying to understand this always gives me something of an talking about is the definition of conditions of approval that is to say the drug that you're relying on active ingredient are not  how could they rely on the study for the pioneer drowned in seeking approval certainly here on earth you can really you can rely on studies concerning a different drug it doesn't necessarily mean that two drugs are the same if they have similar characteristics and the touchstone for knowing whether that reliance is appropriate is you have to you have to show that it is scientifically appropriate to rely on on the different drug interest for about boston talk about the example if you have if you have a drug a different drug with a different active ingredient but has the say in active radio from as a previous drug you can rely on the fact that the previous drugs in active ingredient was demonstrated to be safe in effect in other words of some sort but no well i'm just trying to follow this so here are all right we have two drugs whose active some evidence in this case that bears that out after all aristotle is effective for up to fifty percent longer than abilify mason and that's quite significant when you consider that the entire one of the main purposes of having and seem to accept the proposition that even though one drug may be a pro drunk of the other one they can still be considered different drugs for purposes of new drug approval that's that's exactly right your honor and that's precisely because when one drug has a different way the way the agency views that reliance something on the following lines even though that's a different drug by hypothesis it's still relevant to the approval of this drug because we can there's there's enough of a relationship was duly given the notice that that that there were certain patents that that might have been infringed by the fire and it didn't take that take that option so there certainly is robust intellectual property protection  about applied for drug which is aristotle in this case and i was in such means the terms such refers back to some drugs originally mentioned just because aristotle relied on a different drug doesn't drugs referred to as simultaneous reference to two different drugs and again so i think that what we're saying is that i mean the term drug is context sensitive and doesn't necessarily mean the same thing every substance i mean there's there's various gradations even with then just looking at the term drug so it's a highly context sensitive term and the idea that you could invalidate us as a reasonable based on that kind of structural inference  patent law is it is a different matter and i think that's one of the reasons why it is reasonable to interpret the patent sort of occasion provision a little bit differently because i mean that's a really a prophylactic measure that's designed to capture any in harmony that is to say the way i'd sukkot would like to read them when that protect from that patent infringement problem are with that make no difference exclusivity which expired in two thousand and seven can be sort of indefinitely extended by making subsequent more modest modifications to the drug there's no question in this case one of the oddities of this case there's no question alchemy is didn't rely whole drug ahead who's operation has been well known for some time and i think that's exactly the kind of thing that congress contemplated in creating with the two pathway was that the kind of companies wouldn't have to reconstruct clinical trials with regard to drugs who effects are relatively well known now i i think i understand your argument they're arguing for a certain symmetry of reciprocity and you're saying that agency doesn't read the statute that exclusivity sometimes a drug applicant may try to rely on an old study to avoid exclusivity when in reality it's trying to copy a newer drug and we've rejected that of locks and so the last kind of works in both ways i don't think that we have any in any way read the statute to be you know not harmonious i think that this is just a reasonable way of the looking at the statute that reliance is something quite different and does not necessarily relate to the scope but it doesn't prevent others from building on the story out of existing knowledge to develop their own this really is a good case to illustrate why it's important that innovators be allowed to rely on the story out of existing knowledge because the purpose of the  approval would require taking patients suffering from schizophrenia taking them off their medications and do a clinical trial where some of them get placebo in other words would not would not get treatment in order to measure the  perhaps you know that's not a good deal but if i guess my question is since you the argument is that you have created something new which you have been able to do that b one doesn't get a long has have you done that in other words you're arguing that it's a new drug yes aristotle use a new drug it contains an active morry that's never been previously proven that's why we already do chemical entity entitled to that five year budget was that you are entitled to the five year about the scope of the three arrests of seventy four the four man which is what's given rise to this dispute and made it sound like you were saying that if the agency had read the statute in the way that it suga suggest the statue should be read in other it makes it sound like you're saying that that would be forbidden by the statute i do so i think that there are two two step answer number one i think there has to be some limiting principle beyond reliance and i think you know your colloquy with my friend and his opening argument has brought this out that it can't statute requires the conditions of people to be of such drugs so the question is what's the same drug what is close enough to it to adopt my friend's phrase the agency i think has reasonably decided that active moiety which is broader than some conceptions agency is on very solid ground concluding based on its experience of you know physiology medicine and chemistry that when there is a non esther over one bond that separates one drug from the other you keep you just can't say that those are the same thing because asking is if the agency had a different interpretation where it says for example all products are the same drug then activists wouldn't tell you much because it deferred to an interpretation that went the opposite way but it is sounded like you were saying the agency couldn't even do that  statute and it wasn't clear to me why the agency couldn't do that it didn't obviously but my answer is as long as it is rendering the reasonable interpretation of what it is what it means to be the same drug yeah i don't think that it could just and the medicine the new medicine that wakes up your muscles were the same drug i don't think you could i don't think you can i hope that answers your question but the act of noise has is a bright line that the agency has drawn not just because it makes scientific sense but because it's important to have a great line for the purposes of this statutory exclusivity you don't have to have such a bright line for the patent certification provision you can just have to rely on to be the touchstone because all of happens when you have to certify the patents if you go you look at the patents listed in the orange book and you see whether there are patents claiming that substance and you certified but if for example the patent claims only the molecule error personal and my client's product doesn't use the molecule are errors all it doesn't infringe and so that in those circumstances the brand doesn't sue but if the brand does do within forty five days it gets an automatic thirty month stay on the f d a approval this goes back just around to your question the patent certification provision is baked into the approval process in that way that it stops the approval for thirty months while the parties litigate whether the patent does in fact block the new drug and a patent can be written more broad only then active moi could be written to cover for example a whole class of active ingredients it could be written to cover a formulation that includes in active ingredients as well and it can be written to cover a method of use so the part of the pioneers free to develop recently concluded that if it's the same drug that it's locked and that includes things like salts and asters but it's not the same drug in that sense and aristotle is not because of its different chemical structure but it's not a lot and to remove it from the market you know would be depriving patients of as mr whitaker mentioned at the end of his presentation you know of the only drug on the market that has the six week goes and the different chemical structure as the f d a acknowledges in footnote eighty of its decision used to meet the requirement of the studies need to show whether or not our meat was a factor for use in the fundamental problem here is easier in wording those lines for purposes the tablets it's because they're trying to take a short cut to your later innovation where we