product expired what look do you what do you seek to gain from this if you are successful what in other words what what harm do you believe this suit will remedy the harm your honor is the inability to market what all parties seem to agree at this point is a non infringing product tobar twenty eight two thousand and eight when the brand exclusivity expires without a curt tory judgement apte x will not be able to do that better fact watch with certainty on the top twenty eight and there is no evidence that that will happen no one knows certainly not mark what the intent of the first filer is so at a minimum apple texas looking at least a six month away in watching again what makes this case even more egregious than the prior cases like erica is there is no dispute here this is a non infringing product workers told us over and over after tax couldn't possibly infringe they couldn't possibly get sued because these patents have been disclaimed and yet we sit actually of whether there's been a forfeiture decision or not we're not aware that they're even aware of the issue at this point much less the court forfeiture the decision that was given to us supplemental authority or to the court was an entirely different drug product that has nothing to do even a reasonably prop decision from this court hoping that there is jurisdiction and we would submit that this patent can't possibly be infringed again as tex argued in its summary judgment motion below it was unopposed based on the patent disclaimer judgment under paragraph big day for the other two patents you can never get a trigger date under a b b your c c each of the patents because regulations require you to change that paragraph or do a paragraph three meaning you will stay off the market until that patent expires that's what happens in a patent loss i see so that takes it out of the the the absolutely are that's what i meant by it's irrelevant not in the mix so we go patent by patent we have the first earliest cat is now gone they're not maintaining a paragraph or two that anymore no one is not after tax either and if you don't change your four to paragraph three f d a deems  binding precedent authority on anyone much less this court and that's the problem we have with the argument that possibly there could be a forfeiture bent what merck is trying to do is set this court up as some type of super agency to make this determination now well there's already been a possible forfeiture so we don't need to worry about exercising jurisdiction here we think that misses the point the point is after tax clearly has injury in fact here sufficient to establish an article three controversy under the court's precedent care of for example to use the court's own words if after x has a product that it correctly believes doesn't infringe and here obviously everyone agrees that's the case it has a right i repeat right the court said to in all the cases for which there are covenants and now we're going to start to see disclaimer cases it's the inability to mark that market that admittedly not infringing product for any amount of time whether that's before the earlier patent expires  after the waiter patent expires and we don't believe characters was so narrowly based on that i know everyone keeps pointing to this footnote and carol the fact of the matter is in the care could decision the court didn't focus on the fact that absent a judgment yes merck we can distinguish this between the chemical case in this case because merck has said it makes all the difference that there is a covenant there and a disclaimer here we agree there are different we think this case it's worse because in a covenant case action which does makes it all the more egregious because why would congress i mean let's think about why would congress seriously and ten that it's ok to use the declaratory judgment mechanism to trigger a forfeit which there's been a covenant not to sue in that can't be enforced but somehow congress would say setting up a barrier to generic entry based on displaying patents that remain in the order book that can never be infringed does that the pfizer logic to use the system to set up a barrier to generic entry based on patents that no one could ever infringe could not possibly been intended by congress or foster the purpose of this bill if you look at the legislative history cited throughout the grease in this case strategically by doing so they could avoid a court decision that would trigger this whole failure to market event and clear up the generic bottle that the brands knew that congress purposely enacted this very tory judgement provision to prevent that because congress a generic has to address them a generic has to knock them down or it can't get to market at the earliest possible time so we think this ball squarely in the purpose intent of the statute and that the patents have been disclaim is completely irrelevant in the if you get a judgment of non aggression or invalidity on the two patents in question what does that do to the day you can commence sales when it does your honor is the day that decision comes down the seventy five day period for the first filed to market starts ticking if the first pilot doesn't hit the market before that seventy five days are up exclusivity is gone completely for it but that same scenario will occur on october twenty eighth two thousand  assuming high tech begins marketing on that it's a little different your honor in the one scenario the seventy five day clock at they fell in a market that seventy five days exclusivity completely disappears and forfeits on october twenty eighth if it's not forfeited before that it will be triggered it will start ticking and then app attacks will have to wait one hundred eighty days so a prompt judgment from this court or decision from this court is necessary to start the seventy five before that your clock a week or two that right which notes it would have to be within the next couple weeks it's going to my calculation it's next thursday which a prompt decision which we would suggest is still were addressable impossible your honor because there is no need for ema acknowledged congress directed in mandate the federal courts to hear jurisdiction to the maximum extent allowed by the constitution if there is an article three controversy the district courts don't have discretion anymore to turn away these declaratory judgment actions because congress said they're critical to opening up the market so we would suggest that this court could enter its own order saying there's jurisdiction that these patents could be infringed that would start the seventy five day period  offer an analogy if the patents had expired and appetites came to the court and said i would like a judgment from the court that we don't infringe because patents have expired that would clearly be outside of the subject matter jurisdiction of the court because once the pat book set in motion a set of circumstances that resulted in harm that can be addressed in some way then perhaps there's a case or controversy it was the sort of thing that w case with respect or i think that makes no difference when the patents don't exist they don't exist now in the character of case the patent still did exist it was jurisdiction for the district court to issue a decision of not infringement which would have been based on the covenant not to so now question that the patent still existed no question that the court could have jurisdiction over those patents the only question was whether the covenant ousted the jurisdiction recalling that the covenant was given after the declaratory action was filed so there was a live controversy before the court and the question was did the covenant not to sue moot that controversy but the patent still did exist and calico also there  were looking at a five year delay a five year period within which generic competition would have been precluded and the court made very clear not only in footnote fourteen but it page eleven of the slip opinion page twenty nine of the slip opinion the harm was not that there was an exclusivity under the other patents but that cargo was affectively being prevented from challenging the basic patent the court said that at least three different times of the harm here and as a matter of fact that the  majority opinion criticized the dissent and said the dissent doesn't seem to understand what we're talking about here is that character was being precluded before the basic expires well of course it as your honour's have pointed out a extends till october twenty eighth because that's a lawful up monopoly mark has a patent and it was held valid beyond the october twenty eight merck has no monopoly over doors on the products i disclaimed the patents that would have protected the combination products out two thousand and eleven and it asked twice ask the f d a to delist the patents now it seems to me if the question is not the patents exist because they don't does the f d a aren't book listing exists and shouldn't exist that is not an issue to be addressed to this court or to the district court in new jersey that's an issue with the f d a and as your honour's pointed out the f d a has ruled in a parallel case in trigger here so that's a remedy that if appetites has any remedy at all it's with the if the f a a now beyond october twenty eighth it's correct that right now high tech has a possibility of one hundred eighty days of xmas city to our knowledge the f d a has not told high tech that it has that right and it has not told app attacks mr rico xenos differently it is not told after tax that it's not going to get approved on october twenty eighth but if high tech has that exclusivity that's not gaming the system that's not an abuse of the system that is the remedy that hatch waxman provided for and there is no five year delay here me all of that app attacks wants is jump in at the same time the high cat high tech as it talks about high tech having an improper head start there's nothing improper about high techs head start it was more diligent than apa techs was there is no reason no bucy or no reason to destroy any exclusivity because there's been no abuse but then again i come back to the fundamental question how can a court say we will make a substantive determination on a patent of those and exist anymore but also like follow up on the on one of the questions that one of your honors asked which what is going to be the effect of a decision it will first i would submit that this court cannot give a substantive determination on the question of infringement as a matter of fact if you if you choose to treat the patents as though they still exist even if they don't well if they still exist and they did infringe because they do exactly what the claims cover so i think that's rather a circular argument to reach that the determination they don't infringe you have to first say the patents don't exist and that's the feeling of jurisdiction but even under this court's rules if i'm wrong and everything i've said  and you choose to to issue a decision under the court's rules and then they will not issue until the seventy five day clock is already past your honor is correct that seventy five days from october twenty eighth is start marketing on october twenty eighth it has its f d a approval it fought with us on a way up to this court to get the right to sell the products it's going to stop marketing when it has the right to do it in which case any decision this court renders is going to be moot at that point if i was wrong and everything else that i said so we said that there are many reasons why the court like subject matter jurisdiction one is that the patent those patents don't exist anymore walked into this knowing there was a prior file or knowing it was subject to that right of exclusivity and now comes here and complains that as a result of what it did it is subject to the requirements of the hatch weitzman act well that's not an injury in fact  we did have a point that they didn't have tentative approval you know mr cosey now says they do i have no reason to doubt that what he says but again you have to consider whether there is an effective remedy here and as i said before even if stock will have started to run because i text going to be on the mark and so are you saying there is no way that this court could at assuming it acton and medium only to prevent the  commencement of the protected period in a midterm turn in this court would have to issue a final decision on the merits which is not before it the question of summary judgment of infringement is not be what is court the only issue before this court is whether judge mary cooper should have taken jurisdiction of the case the resolution of that issue if in favor of appetites will be a remand to judge cooper judge cooper then has discretion to decide whether she will accept that jurisdiction i respectfully suggest it would be an usurper ation of that authority for this court to say you don't have any discretion in this matter and when you no matter how you run out the clock the seventy five days can't start in time to make high tech forfeit before october twenty eighth two thousand and eight and there is another issue and one which the court may not have to get to in this case but it but it's an issue t one legitimate question is can a generic be subject to for picher when in fact it's precluded from marketing anyway by some other event and a second issue is that the ponder the best pharmaceuticals for pediatrics statute there's a provision that says if a generic loses any portion of its x was sooty due to peer pediatrics was city that gets resort so in fact this case may be mood for an entirely other reason that any decision that came down now even if it happened before the seventy five days would simply say well you can't market because you're in the pediatric period but the pediatric statute says we restore that at the so for judged very brief first off to say that the patents doesn't exist it again misses the point here they remain in the order book and there's no difference between a disclaimer and a company as far as the practical effect neither can be assertive  the orange book and create a barrier to economic entry secondly the remedy here there is nothing to remand for if the patents are truly disclaimed as merck says and we have no reason to doubt they are the statutory disclaimers are in the record there is no sense to send this case back to judge mary cooper for her to make that determination this court can do that not only that this court would be directing judge cooper not to act to exercise jurisdiction keep the case congress has already said that congress has said if there is an article three controversy that's it the federal courts must exercise the jurisdiction if the f d a delist in these two patents would that wouldn't give you the b b date you're looking for in that starts this course of events for which there is no return in west after tax can get its judgment which is why to say the patents don't exist is not an answer to anything because they're in the order book and they have to be addressed as far as gaming the system here the bet to make gaming the system in our view is using this claim patents that can't be infringed to hold the generic off the market is judge mare's aware from a couple other app tax cases involving unsolicited  covenants not to sue those used to be the flavor of the month for bottlenecking subsequent filing generics give them a covenant not to sue try to take away the court's jurisdiction that happened in at least a half dozen cases the app attacks there's at least a dozen or more patents and you w does district court decision going to stir it will be condoning the next whoop poll used by the brain companies to take away jurisdiction of the subsequent filing generic and we submit that the gamey of the system that will happen here brands already did the covenants and if you give them this will poll they'll take that as well because there's nothing to lose for a brain company disclaim and admittedly weak an invalid patent knowing that the subsequent finally generic will be stuck by that path and less they can get  correctly judgement if the current holds the disclaimer somehow take it out of the court's jurisdiction will have the whole covenant mess again and carol won't have solved any of the problems we're dealing with here so appetites can get it's harder addressed here