a reasonably simple case what we have here is a question of the title went to a patent term extension in this situation the patent term extension was granted on one basis and that was the prior approval or the approval i two answers to that i would say run from the standpoint of a compound it's simply an easy designation for the interaction of the in the interim or as in the solid state of the fact is the physiological activity is beside the point when it comes to the issue of the term extension that the statute is what where it asked a simple question was that into the it is now described in this application as an active ingredient accompts hold it of that prior for profit and that's the only the statute does not go into an issue of interaction it does not going to an issue of whether one is better than the other and in fact the statute even recognizes that you can have a prior approval where there is more than that curious anything about being money in terms of the same situation and esther an assault info to cure and in this instance the race me that not at all in fact first and fisons it says it's not an issue a product is an issue of the active ingredient now what was in existence as of the time of the approval of the hatch wants to act the f d a had a regulation as well talked about active ingredients and that regulation specifically defined it activity bring it as any component what you have a definition for components of active ingredients by itself is enough that regulation specifically says any component that is intended to furnish pharmacological activity goes on but that's enough it's really all we need for our present purposes and that regulation is plain one point in this case because the experts from the plains have fully acknowledge that when you're dealing with a race made there are two what do we have here we have an entire product you're saying it's not a new product yet you're on it is not a new product because you have to focus on the active ingredient the executed is a new product are they have to then and that's what i'm trying to understand active ingredient in the prior product was the combination of the two in the uterus so there was something it's not this active ingredient is it it was something else it was a combination of two things it's not be active ingredient in this l tell it was there the rich family compound that was the active ingredient in the box and i think the record is clear that even the plaintiffs experts in this case acknowledge that the compound that was the active ingredient correct i would respectfully dispute that your honor the active ingredient is known as watson which in itself means that there are two active that your argument i mean it's not just my position it's also the regulation that says you look at the term active ingredient and he asked the question what's the active component in this instance there are two active components and i also  to the extent that there is an issue as to what one means by active ingredient one should look to the f d a regulations in the f d a regulations as it is very specific on it so if you look at it on a component by component basis and fact that's what this court said back in the article partnership case it said look at it from the standpoint of component by component or ingredient mind reading and recognizing there's a distinction here and in this instance the there is no dispute and in response to one of the requests for admission for example in this case and other peers at all the ninety three in the appendix the plan is acknowledged that in the prior litigation about which this court is quite familiar the players agreed that level for watches and is one of the says it doesn't qualify for the five year exclusivity provision so the f d a has looked at that and has recognized that you don't simply say bliss is a prior race of age and consequently that's the active ingredient and that's into the inquiry the is not entitled to that five year period of exclusivity so to the extent that there is an issue dealing with whether you look to the underlying components or not the f d a has done so already on the regulatory side i see my time i occasioned the grant of the patent term extension reconciling graco and price are sure but first let me let me say that that i agree with my friend and also that the government is anika us here that this case does not turn on reconciling blacks on pfizer that may be the case in the next case you're going here this morning but it isn't for us but with glaxo pfizer and photo cure all have in common is that all three of them deal with the meaning of the including any salt or restaurant language in the statute that doesn't apply to us we are talking about salts arrestors here and there is no statutory law which congress could have very easily written including any anan but they did they clearly did not do that so it's a different category now whether they're consistent or not i mean i could reconcile them i could argue they're inconsistent i mean glaxo glaxo involved the question of whether you get it is the one that's closer on point because it deals with the patent term extension and the question was there or if you've already gotten regulatory approval of two salts of a common base molecule and you come in now with an estimate of the same because the souls of the yesterday were not so also masters of each other even though they had a problem if i was the issue was was a very different concepts there the question was not should this extension of the great and bango by the supreme court and i believe it because the pfizer case arose in the context of what does it mean to extend the pact for infringement purposes if the patent claims two different salts only one of which was the subject of the regulatory the way once you've extended the patent does infringing the second the claim of the second assault still apply and the answer was yes so one can reconcile them but if you can't reconcile them then the blocks i was the one that would govern but again in our case need to read on where my friend stopped intended to florida's pharmacological activity or other direct effect and if you instead turn to the active moiety definition which is a little bit different because they were it doesn't talk about intent but what it says is responsible for the physiological or pharmacological action of the drug substance either definition what's intended or what is in fact responsible for what is responsible for and intended to be responsible for the physiological what the government congress left the application of these standards to expert agencies at one point on which plaques on files were greeted fortunately is that those determinations are entitled to great deference both both of those their brief but the standard that they actually applied in approving the patent term extension in this case was the active moiety standard which as i understand it is the harder the tougher the to stand so they say they apply that entitle to a distinction and what an extension and what is entitle to a patent he says that those patentability requirements are different from the extension requirements of course there's some truth to that but does the patent ability requirements in me that extension it was given a separate patent is it a separate ingredient is it a separate product i should imagine instances fortunately not this one where the answer might be no it might be somehow patentable some dramatic use for example even though had previously been approved but but that isn't our case here  would actually do lineup what they i mean in substance what they're arguing here is just a new variation on that thing they found a new way to say what martin said in a case we tried in west virginia and one there that this court's an earl yes exactly exactly or are that's the context in which it happened there would be a patent it's exactly our situation there was a patent for a russell and that was approved for marketing perhaps as we as we see here and put separate went through the f d a process we would your answer be the same terms of entitlement to a separate extension well i guess if it hadn't been subject to an extension based on the and threatened effort to separately contain approval judge newman that's an interesting theory i'm not i'm not over they didn't get to piggyback on on the efforts and in getting the f d a approval for marketing over locks and they start from scratch it is a new drug for purposes of getting f d a approval when you go in there with the single an asmer as they did so there is no there there is no double counting here they started over they got better for just that time in the past expansion and again both the f d a and which consultant pursuant to the memorandum of understanding and the p t o determined that this was appropriate because in fact this was the first commercial marketing approval of the enhancement and the fact that the rason had previously been approved the p t o was always in consistently taking the position that that is not the same product it is not the same active ingredient it is not the same drug it is not the same active moiety and as i said here we've got t had been previously approved for commercial market or that it was an active ingredient or in a trust and i think the record is is quite clear on that and for that it's it is just fundamentally a burden of failure doesn't appreciate it if if there are no further questions i think i would remove my argument we we believe that both on the deference senator so the determinations the consistent terminations section that deals with patent term extensions doesn't really say that there is no statement in two eighty two about such a presumption hopefully turning to the question of the scope of the claims and using that to define the product that again what this does is that it really does turn the process upside down it's not know how the process is worked if you look at the record in this case the there is no guidance to the f d a provided by the patent and trademark earlier approved product and i would respectfully refer to the court to u s patent for nine one one nine three two which has a very interesting dialogue and it dealing with a pepper lanham in fact was never approved of as an active but it was in that particular product but at the end of the day the last step in the process was the patent office took a look at the scope of the claim and determined that that did not cover that claimed product because it said nothing about white pepper about it so in that instance there was no term extension granted because the claim when finally looked at the end of the process didn't cover the active ingredient and that's exactly the way it worked here if you look at the memorandum of understanding that memorandum of understanding says that with respect to that determination of whether there was a prior approval for that active ingredient it was left to the f d a that's exactly what happened here and the f d a came back and he answered and specifically referred to glaxo as the basis for forming that conclusion it relied on an inappropriate application of glaxo to find in that instance that there was no prior approval for leavell flights and so i submit there was no expertise in that determination was an improper construction by the f d a and to the extent that there is any expertise by the f d a in determining