finding and that single fact finding was that the first lady applicant who is not a party to the case roxanne had forfeited their hundred eighty day exclusivity period under a particular forfeiture provision in the because it had been more than thirty months since they had filed and had not a painted of approval the court also attended to one particular fact that we had referenced in our briefing that indicated that there was some sort of activity a regarding change in review of the requirements for approval which is the exemption to the forfeiture event that that was in question and so my reading in our reading of the district court's determination was she found that the hundred eighty day period is not a barrier to two pars market entry because of the tentative approval for which are and our position is and we think no one is going to be standing in front of you today say yes the district court was correct roxanne forfeited we both agree and i think in plaintiff's brief it's a note five on on the on the structure which is that at some point implicates the record that was in front of the f d a that we don't have regarding roxanne's and yet it was in front of the district court and so in this case we think there are a couple of fundamental problems with the district court decision regarding roxanne's exclusivity in that even if we were to agree with you that perhaps it was incorrect to determine that there was a forfeiture which seemed to be the basis for the district court's ruling and we sent it back to district court would still have the discretion to deny the the declaratory judgment act fact that there hasn't been a forfeiture so that your client is still sort of behind the rock sand and it turns out that tomorrow the f maintain standing throughout the litigation so we can and it likely that if we send it back this would really do very little other than perhaps start the lawsuit running and only to have it similar to that to this patent we just finished back discovery we're waiting on a marketing decision and the patents are so similar that they can readily be litigated together what our concern is and the real tangible harm here is that we get through the trial in the case we get a favorable decision we invest all the money and it turns out then after we do that the f d a comes back and says no you don't have a decision on everything and roxanne we've been undergoing some change a review of the requirements for approval there's been a lot of activity we only see what publicly available we don't see the whole thing but f d a could make that determination and here we sit a year from today wanting the launch we've invested the money we want our case and now have a says there's exclusivity roxan still doesn't have approval and we don't know exactly what's going on there and so we think that tangible harm and that the bees patents in particular expire in late summer mid to gee i didn't reach that problem because she found no case or controversy is there is there a pleading problem here because there is no specific pleading on any for put your or even the fact that lead but i think in this case there's not an issue of of the pleading because if we don't have to plead that roxanne is entitled to exclusivity we may have other defenses if we get into litigation with f d a there may be other arguments this is an argument and in the two principal cases addressing this issue the caricature case and the tev of the a c i case the language that the that the federal circuit there used was removing the possibility of a delay in clearing the path for approval and this is the standard set of things that are hacked that happened all at waxman cases we don't have approval yet we're still a to getting other  us at the the day that we are faced with f d a approval and the f d a says there there is an exit city in place we want to preserve all rights we have to challenge that and so is it read in paris contro as to whether or not rights and one hundred eighty days of a city the only provision that we have control over whatsoever is the ability to obtain the court decision and cause the court decision trigger every other  the us to resolve the question concerning a third party that's not represented here who as you put it hasn't been heard and that neither side here can control where we're asking for quite the opposite your honor we're asking for the roxanne was improper because roxanne was not before the district we weren't having any breeze through roxanne correct and neither did the district court and so the district court didn't have the record of rocks and  roxanne for for the vix exclusive in that's simply not there her or her opinion that soon your views that's a clearly erroneous finding of fact that is a clearly erroneous finding of fact and as i've carefully perused the wording i don't think she found specifically that we fled that roxanne had forfeited she somehow gleaned facts from our pleadings that led her to conclude is my interpretation of it that letter to conclude roxana for that but there's no pleading anywhere that we've made that roxanne has engaged in a forfeiture of that but getting to judge newman's point the you know it's your burden to establish that if you have standing it seems to me th because the purpose of the declaratory judgment the standard purpose for the declaratory judgment act is to resolve legitimate uncertainties and so for example if i want to file a declaratory judgment action that someone's patent is invalid i don't have to stipulate that i infringe the roxanne create an actual controversy between parr and plaintiff because they've listed this patent we aren't booked it is a barrier to us coming on to fix exclusivity exists when we try to go to market then we are prohibited from going to market and so that's something that is beyond our control of the statute explicitly gives us control visa v the court decision trigger and in both the character case and the have of the s i case the court found that unknown i believe i believe the court can simply by relying on the caricature case we think the caricature cases controlling and that there are multiple patents in the or in the book they sued on fewer than all the  district court have to resolve whether roxanne a third party to this action at forfeit is the answer is not it is part of the burden to show that it faces a heart which is real in images that it is that it is likely to be held up the not whether or not roxanne has in fact exclusivity this court dealt with this kind of issue expressly in the janssen case in two thousand and eight in genesis there was potential partner the second app it's a very similar circumstance here in that case he was the first applicant aftertax was the second applicant aftertax argued two potential harms to it in de lay from the the first applicant tiva doesn't want to send what if they suffer some kind of delay then we might be held up if we can bring this d j action now we'll make sure that that potential risk that the first application delay doesn't hold us up this court held that that was not a sufficient allegation of real emitted harm to support jurisdiction and this is what it says pacifically because it shows what the standard is here this is by forty f third at thirteen sixty three at no time between the filing of the counter claim through the final judgment was there any basis to conclude that tivo will or is likely have here no one actually believes that roxanne has exclusively let me tell you why there are and it was filed in june of two thousand and seven it's been almost fifty five months fifty five months we all agree the statutory requirement is to get tentative approval in thirty months they still don't have the parts council's pointed to a citizens petition as potentially tolling the period to get tentative approval that's a suspicion was pending for six months it was filed by warner chill conference february twenty ten it was answered by f d a it aug twenty ten even subtracting six months from fifty five months is roxanne's rights what the district courts fact finding was is that it was very very unlikely that roxanne had retained x or seventy that there was every reason to believe it had forfeited that we know all the parties believe speculative at best and does not meet the article three requirements of actual or imminent injury for standing i believe the district court did exactly what it is required to do under article three determine whether or not the concrete horns here to support in vocation of declaratory judgment jurisdiction and it found that there was no concrete no real harm because the idea that roxanne still has a this case actually presents an issue of first impression if you go beyond if you decide that there is sufficient or near this is the first cases come up your honor that in actually involves the forfeiture provisions that were introduced in two thousand little b b capital a that's the citation this is the provision introduced in two thousand and three to congress made a very important change it's no longer the case that any and applicant can bring a d j action can bring an action that has the effect of forfeiting exclusive instead it's only a first applicant or any other applicant which other applicant has received tentative approval congress cut it back but but it does say brought by that that but but here's the reason why you can't have it go in the other order you can't get the d j actually invent get it kind of rule two problems with that first there's a seventy five day window once the trigger is put up minus seventy five days earlier they had forfeited because it said you clearly says that the date that counts for the seventy five days is the date of declaratory judgment and there's another reason your honor the idea here is it's meaningless formulation if you get the d j not infringement if the an applicant gets the duty of not infrequent they can amend their formulation and go on a six months or a year or more to get their tentative approval and their final approval you don't know it's that it's not necessarily the same formulation gorillaz in that during the approval process there may or may be some give and take and some provisions to things like labeling things of that sort  because the applicant amended its formulation that can't be done in fact in this case is a fact that have arisen over the last month we brought them to the attention of our roxanna said they name and therefore make sure not to pursue the formulation they may have ended different formulation it is not unheard of it is allowed it is not if it does happen i don't have to to six for how often we know it does happen certainly if an advocate is able to obtain d j jurisdiction in order to trigger acts of civil and then has trouble getting the brule it could easily and to get approval having already cleared out the exclusive of the that's not the way the statutes written it doesn't make sense to construe it that way so to get these issues resolved early your honor actually there's two aspects to watch it one is this uncertainty as patents are certainly they didn't have a covenant they can quickly clear out any path and certainly that's not this case the second issue which is the one this case presents is a much harder issue this court the d c circuit at gave all struggling with how to make the hundred eighty deg passivity work one concern is to make sure that it works in a reliable and predictable way that means that it's not always in the interest to fork excessively as quickly as possible or conscious conservatives under the law but at the same time if one hundred eighty days is to act as a real incentive for parties to file patent challenges they have to have a fair opportunity to count on one hundred eighty days so when you look at the two thousand rechange is there's counterbalancing changes they introduce the thirty month kind of approval requirement leading to forfeiture so that in fact you make sure that that first up is working towards approval at the same time they narrow down the d j the trigger  forfeiture from a declaration an infringement to those later on but ends who have tentative approval that's perfectly sensible balance it's true that it may not be the fastest way to ensure that ex forfeited as much as possible but that's not the statutory goal the statutory goal is to make sure is to balance the incentive to file the patent challenges with making sure they don't get parked too long in the same way that has  very good delicate balance between preserving our incentive to develop new drugs and uses for drugs and the generics incentive to violence so you know our concern here is what part has been for the extraordinary in a case where no one actually believes  harm and to to be able to bring your action before even they have to do to provoke to paint a declaration potentially not infrequent on a formulation that may not be provable itself and we think that fails for those two separate reasons supreme just to address a handful of things quickly at first like to address plaintiff's position that tenet approval is a jurisdiction requirement for d j that's just flat wrong it's in our reply brief in careful detail provision provides that from the decision in the case at seventy five days later than the forfeiture of that there's nothing in there that suggests that ten of approval has to happen before we can even bring the lawsuit that's just a guarantee of  two sentences later she says in making a conclusion as to standing i must rely on defendant's allegations in the counter claims which alex allegations indicate that first filer roxanne forfeited his exclusivity in that sen she doesn't use appears or any qualifying language she somehow derives something from our pleadings and we can't figure out what and she says here allegations indicate that first file roxanne forfeited its exclusivity so that was at i would simply refer the court to the character decision page twelve eighty nine and page twelve ninety three eleven and there the court in that case noted that this can all be resolved if instead of giving us a covenant not to sue they agree to a stipulation of not infringement which removes this very altogether so their concern is about litigating the case they don't want to litigate a stipulation of non infringement