version of the statute that applies here section thirty seven of the america invents act does not take effect until september of two thousand and twelve and in any event to apply it to make those work were patent would be unconstitutional i like to start with the the provisions of the actual take effect upon the expiration of the one year period beginning on the date of the amendment of the sec and second it provides that the actual apply prospectively except as otherwise providing the act the actual apply to any patent issued on or after that second date section thirty seven changes only the second part it's a typical retroactivity vision and to be sure once the act it's effect it provides that it will  as to pretensions standing your honor we don't think that that applies here in the context of an interview you're seeking to appeal well let me ask you this suppose that the p t o had granted the patent term extension without no fuss no muss read it presumably you would not have a right under the a p a or perhaps you don't agree with that but tell me whether you agree or not with the you could then seek review of that decision by the p t o in a district court under the we could not your honor you cannot so the question then is what since since the reason you could not presumably is you would not have a protectable legal interest in cases the question here is whether the statute is set up so that a determination by the p t o as to patent term extension is something that an opponent a third party describe the reason you do not the reason it would seem to me is you don't have the kind of legal interest that the a p a requires in order to have a course of action right under seven o two of the but but here the question and the supreme court has made clear that in order to intervene to appeal all that is necessary that we be agreed by the district court's judgment so we did it play out as you say of course all we're doing here is stepping in to defend the administrative judgment it just seems to me it's a peculiar situation in which you now find yourself in exactly the same position as you would have if the p t o it simply granted the term extension in the first instance you wouldn't have been able to take any legal action under the initial grant situation but you say you are able to take legal action now and even though your situation is exactly the same it no patent term extension medco appealed that the p t o felt that bigger slee in the district court and only once it decided not to appeal that for whatever reason not necessarily because it agrees but i'm not sure that would matter a p p then has the right because it is injured by the district court incorrect decision it has an article three injury in that it was injured any more than it would have been injured by the p t o s action in granting the patent term extension because in either case you can't usually have preserve your defense in a potential infringement action you're you're not going to be collateral is stopped presumably from arguing or at least depending on what effect this action is and has your proceeding here if you had simply said ok that's that's between the p t o and medicines we can now proceed to defend on the ground ground of view the sacha cannot constitutionally be applied to the floor for patents because there were four patent expired in march of two thousand and ten went through extensions and there were interest engines your honor but those extensions were simply to protect the ability of the judicial system to decide constitutionally applied the supreme court has never against a constitutional challenge allowed congress to revive a patent or copyright that has run its entire original term and expired and if the limited times for business have any meaning it must foreclose the ability for congress to go back and perpetually revive patterns that have already spent their original term but we don't have a situation here that's will revive never upheld such an extension in goal and presents a very similar question to this one and we would ask that if your are going to say that section thirty five doesn't apply in section thirty seven is takes effect immediately that you decision regarding the application which is subject to judicial review in the date of an act meant of this act that would seem to apply here it would if it already took  or decision still not final in the sense that it was still under or subject to review either within the court in the petition for rehearing or before the supreme court you're right i think only  event that you had gone through complete and final review then under clout it would not apply even though it fell within the pocket of things to which it was opposed to the plot but in that event we would we would ask the court if you do agree with us on the effective date issue rational i mean i preach it that you know we don't know why congress and sometimes like you typically we look for some kind of rationale in order to satisfy ourselves that the structure that congress has wrecked it makes some kind of sense what would be the reason that one would structure the statute the way you argue the statute must be read well one reason would be you know the very concerns implicated by applying it to this case you know we don't know what compromises were struck it could be that there were some people that intended us to be standing you're having this very argument we don't know right it could be the f d a give the f d a time to implicate this complicated system to allow the public to know because that wasn't the law before when something was transmitted eastern time on a holiday on and on holiday when when it was transmitted from the f d a that would give them time to implement and we also know that three other times where where congress in the american vets act x pressley provided an effect definition you should how you should read section three seven so for example the provision that allows pre issuance submissions by third parties with respect to contact with patients that doesn't take effect for a year expressly doesn't it's eight b one twenty five statute three sixteen but when it does take effect it applies to any patent application filed before on or after that effective date so we know that congress consider each of these things very very carefully or not i guess doesn't really matter this court is just indicated me ready and able to enter the market during the dispute at term then we move to the issue of production standing on and on that the injury they assert is no different than the injury and gentle competitor could assert with respect to any grant of a patent term extension were get here makes a difference whether congress would actually have intended to foreclose a p a review if there was direct appeal from a grant but would have had some reason for permitting review in the strange situation that's presented here a t p hasn't suggested any rationale why congress would have wanted that and in fact congress adopted a different scheme because it's not the case that a t p doesn't have rights here of course they have rights but congress established that the way to assert those rights is in private infringement litigation under section two seventy one and two eighty two they could have filed a paragraph or certification that would provoke an infringement suit and then section two eighty two expressly permits them to offer as a defense a material failure by the director or by us to comply with section one fifty sixty with respect to patent term mix congress made specific provision for that in private infringement litigation and the reason we're here is that a t p does not want to follow that route and they're very candid about why they don't want all that route they don't like the procedures and standards that congress established for that route they don't like thirty month stay they don't like the standard of review and that's why they assert they should be entitled to bring this case here they say that they they it's an injury for them to be forced to hazard an infringement suit but those hazards are just the government changed positions the other side wasn't being permitted to do anything that congress had indicated it should have been for close from doing but here we have a concession that congress did not adopt a scheme in which a p p would have been permitted to appeal the grant of a patent term extension and so it's a p p s burden to show that congress would have had some reason for distinguishing the situation here where they are effectively doing exactly the same thing from the situation where they've already conce they wouldn't have any right to media traditional if we been talking in terms of prudential standing which has always struck me as a cumbersome and almost misleading term but that's the term that this supreme court stuck us with  it fair to say that at least in this context what you're really talking about is whether there's an a p a cause of action period end of discussion i think that is correct your honor and in fact this court in the syntax case specifically said that the issue of prevention standing of interest and the issue of you ability merging is context because essentially the question is did congress intend a party in this position to be able to bring an action through this procedure although if we go all the way back to associated so station data processing against camp i guess it is that zone of interest was adopted in place of in its stead deliberate which was that the brilliant position but i think since justice douglas in a lot of ways the supreme court has moved in other directions and insecurities apart for securities industry association it's pacific we just said this is a question of congressional intent you're looking at the scheme you're looking at the purpose you're trying to decide whether congress intended this to be the vehicle for this kind of an don't think that was a viable theory then but it's certainly not a viable theory now when they filed a stay application the point of which is to try to prevent the p t o from doing what it would otherwise do when they are challenging the p t o s view of the law and where they are claiming that an act of congress is impaired by denying it intervention and therefore has no right to intervene and are not impaired the court said in chat and versus mandate for the same reason they lack credentials standing which is that they can pursue their rights as congress meant to and them two under two eighty two you know with respect to time ss your honor we think the decision below was correct because we think a p p should have known at the very beginning of this case its interests and the government's had to verge because this is the second case that the medicines company brought the first case of all the first medicines company case in the second case the show had it pether the intervening or part of intervening with that changed the position of potential standing i don't think it would change the position on prudential standing because i think the court has treated those two issues as discrete and the fact that the party is permitted to intervene at a time when the government is a defendant in the case doesn't establish that it would have the additional right to then come to this court and carry the case forward in the absence of that because that's the point where the supreme court said and i'm in versus charles and this court has said in bowing that an additional burden is imposed that's the burden of demonstrating both article three standing and credentials down and if i may i'd like to address judge laurie's questions about the constitutionality of applicability of section thirty seven to take the constitutional issue first arsons that's what you raised the question the a p is presenting this to the court isn't presented by the facts of the case the question that a p is presenting is can congress take some invention that's already in the public domain and take it away from the public domain and cloak at the patent protection but if you're on a noted this invention has never been in the public domain it's been covered by an unbroken series of extensions during that period of time the f was prohibited by statute from approving any other drug so this is not a matter that was ever in the public domain and what that means is that a piece theory here is something very different it's it's a hypothetical public domain theory their theory as my friend articulated it is those extensions should not have been granted they should have been declared invalid and if they work this matter would have been in the public domain and therefore this court should treat it for purposes of this constitutional argument as if it were in the public domain but that theory is for close by the supreme court's decision in the clerk's versus king's lynn and eight hundred forty three because that was precisely the situation that the court confronted there there was a patent holder who had been granted a patent which was invalid under the law in effect at the time of the grant and a few years later congress retroactively that all of it and that was the retroactive validation that the court on the floor versus kingsland a p says there was never a constitutional holding that's wrong supreme court said specifically that the retroactive application is no reason to question the soundness of the validity of congress action because the court said congress has authority over patents and by terms of the constitution is planner and so then i think we move to this issue of of likability congress has said that section thirty seven quote shout plot to any application or litigation that quote is pending on the date of an atom and now a p p s knowledge here that the provision applies to the medicine company's application but says that nonetheless it somehow doesn't take effect for another year so the theory is that congress intended to say that shell oil is mandatory well is mandatory and is pending means that it is referring to applications that are pending today will congress usually or shall it always a mandatory charge not invariably your honor their hat usually and that's the general rule of construction a radical ated there's the use of the word shout precisely because it had determined that it was being construed as may in some instances but i think the general presumption is that when congress uses the word shout it is imposing a mandatory duty and that means that the court is expected to apply the existing law a law that's created by the american invents act to this proceeding and a p a p does not identify any conceivable reason why congress would have intended a statute to apply to a matter that is pending today but somehow not take effect for another year nor does it explain how the p t o would actually implement such an incoherent scheme and the language and the history of that provision absolutely for close it as to the language the language is very similar to the language of six section sixteen before of this act which this court construed three weeks ago in the f l f m c case non presidential that we provided to the court by letter yesterday the court said it takes effect today and it governed that appeal the language is materially indistinguishable from the language the supreme court held out in martin versus hadiths and land graph as the model for how when congress wants to write a clear statement that a matter  which it right this language is instinctual from that and by using the words is pending congress make clear that it applies today because if instead it had some inexplicable intent that the statute would take effect for a year and then reach back to reply brief here and finally with respect to the history a p says we're relying on isolated or statements on the hill there is nothing isolated about it you read that congressional debate from cover to cover and people are talking about only one thing the opponents of the statue and a t p zone trade association are saying congress shouldn't do this it would be injecting congress into pending litigation that's wrong and it shouldn't happen and the supporters don't respond by saying no no that's not what the statute supporters respond by saying we think it's appropriate to do that here there's confusion we want clarity and this is an instance in which we should inject ourselves into pending litigation there was no dispute about the effect of the statute the just currently there are two other points i would like to draw matters the first is that counsel for a piece of jesse this case should be held for go and we don't see any reason for it to be held for golan not only because the likeability issue we think it's so clear but also because go on presents an issue that's not implicated here the works can go in which the supreme court is deciding what the congress can extend copyright protection to indisputably in the public domain the question there  words that were never subject to copyright protection can suddenly be granted that there's no dispute that that's not an issue here there's no dispute that they were interim extensions throughout the period and continuing to this day the only other point i would like to mention is that only claim of harm is that they believe there would be unspecified public confusion if the final extension order were issued and that that confusion would somehow they say harm a p m p p p p we think this isn't remotely potential standing is not a jurisdictional bar and therefore there will be nothing in the nothing inappropriate about our seeing we're not going to address potential standing in deigned by prior precedent for the reasons i've said we actually believe that the plea could billet in constitutional issues presented here could meet even that standard but that's obviously a judgment for the court and even if the court agreed with that it would just be discretionary which ground the court because justice scalia distinguished without overruling some prior cases but he distinguished them in calling them extraordinary in the sense of they were odd procedural ducks one of which he is as much as said that was just a two page for curiam that's correct you are and i don't deny that it would be a high standard to find that those terms that the steel company court used in substantial frivolous forward again would apply to any case but in the they please the court and we're him apart from the united states i'm here that found the constitutionality of section thirty seven but may be more accurate to say i'm here to try to persuade the court not to reach that issue and who gave four possible ways avoid the issue you know brief and like to focus on the fourth of those which is the extension issue that this patent has been subject to uninterrupted interim extensions that continue through next august and that is never into public domain and therefore the constitutional argument doesn't really apply to this case because the section thirty seven no matter what you think it does does not rest or lapsed that and so that's that's the simple in our way of looking at it that's the simplest way of not reaching constitutionally do you think that would apply if an extension had been granted without even the pretense of statutory authorization the p t o it simply said we just want to keep this this thing alive for your honor i think that somebody some body has to determine that the extension was appropriate that was not authorized by law but your argument is i take it that that the as long as the extension was in place if it is a statute but instead was totally ultraviolet virus act on the part of the agents that would be sufficient i take it to really keep it out of the public domain right and in the sense that we're talking about here well i  think you can actually reach that until you have the may have to be present in this case but i know i'm really trying to see how far your argument goes so i was back to the not in the public domain issue right and i'm trying to understand effect we would then consider it to have the subject that to have been in the public domain i guess looking back on it if you if the court were to look back on the extension and determined that was without but that would change the nature of the constitutional rights if a court determined at some point that the that the extensions were an authorised perhaps yes  saying in supplemental briefing it's saying that the the patent actually actually lapsed as i understand actually lapse the march twenty third last year but in its merits briefs it took a slightly different positions way i read it was being ordered by the district court and we see that as being authorized under five u s c seven zero five in the second to the third and fourth extensions being authorized under thirty five u s c one fifty  six so just to summarize our position is that the the fact that that we have these continuous extensions means that you don't have to reach a constitutional issue and we in our brief we did mention three other bases which the court could to be correct and if that then it could if the district court's decision was correct under the original law and nothing has changed now and you're section thirty seven or the court could agree with a some of them involve statutes but least the ones involving agency action that either of the two part private parties could have sought a p a review of the initial but here we have the somewhat anomalous situation in which a great one of the two parties could not have taken an appeal initially from a decision that is you know adverse to it in the sense that it would have preferred the other they're riding on the cause of action of the other part their defense and that's all we're doing there's no doubt that medco has a cause of action here and we're seeking to intervene to protect our article three interests and the this supreme court case on doesn't  race question how do you know how do we how do we know that the application will be approved isn't it speculation to say that you do have an interest it's not speculative in the in the sense that would take away our interests i mean medco doesn't dispute that we have filed in the enda is there something in the record from the f d a that says if you provide this added piece of information your application will be approved no your honor but i don't think we need that because  it no one disputes that that the the existence of the patent is a bar to our r and of being approved and if the court were to remove that barrier that would be put us one step closer doubt this this alone will not get us home but that's not the test and if i may just address the government's the justice department's arguments for a moment recently thank you your honor i think that my friend from the justice for essentially conceded what congress acted here and that would make a constitutional difference i also know it's notable he doesn't try to defend it that the merits of that point here today and this is not mcclurkin response to mr kaiser's point the clear was not a case in which a p