maynard when you're ready thank you your honor mr chief justice and may it please the court the biosimilars act created a comprehensive and self contained scheme for the early resolution regardless of the actions an applicant or sponsor take along the way the end result is the same patent litigation court should apply that comprehensive scheme as written they should look elsewhere for consequences i'd like to start with the issue in sanders's petition our petition the notice of commercial marketing issue and then turn to the issue in a petition the the information exchange for the federal circuit misread the notice of commercial marketing provision to provide sponsors a one hundred eighty day automatics day that's nowhere in the statute that ruling will wrongly delay the marketing of everybody of similar even when there are no patent rights letter decides that it's going to approve is it licensed at that time well or is it not licensed until the very end of the kobe period the f d a cannot license a bio similar in til the end of the twelve clarify does that mean that the f d a can't announce it's going to approve on the year twelve plus one earlier than the year twelve or i'm not quite sure i understand how long does it take for the f d a to approve the biosimilars assuming you go through phase one and there's and phase two has been finished how long with those brown independent of the f d a approval correct that's right the information exchange and the patent litigation process is completely separate and do you link from the f d a process so how long i want you to go back to justice kennedy but i just want to get a sense of timing how long does it generally take for the f d a to say this is ok affective twelve plus one so two points about that just sort of new york to answer your question the f d a has said that it takes about their aiming to try to approve by a similar applications within ten months of application but there's nothing in the this act in contrast to the hatchback an act that expressed we allowed the kind of tenet approval that i think both of you are asking about and i think you may be asking about the fix that the federal circuit suggested for the problem they've win to announce that it's ok they can't under the statute under case seven they can't make it effective can't make the prove effective until year twelve when do they tell you that they would well there's nothing the statute that it calls for an approval before year twelve i mean do they get a phone call they say the good news we've got it approved in five years you're going to be able to market i mean how does that work know you're on and incidentally when you're talking about cases in the news approval of an application under this subsection may not be made affected by the secretary until the date that is twelve years after the date on which the reference product was first license under subsection a that's the reference product biologic sponsor so the statu subside it seems to me that this process this aspect of the process cuts against you and so far as the one hundred eighty days notice i'm not sure i understand the premise of your question well if the what the one hundred eighty days has to run from some time and it seems to me that it has to run from the time that is lies but i'm what you're telling me no your honor so i'd like to turn to the tax then of the notice of commercial marking provision because i think the text forecloses that reading the text of the commercial marking provision has one and only one time element it requires notice at least one hundred eighty days before the date of the first commercial market yes but there is what you are to notice about what does this notice say and what it says is what you have to revive more than note later hundred eighty days is notice oh maybe it doesn't even say this is not a complete sentence of the first commercial marketing of the biological product license now how could you do that if you don't know what the product licensed is well and i take it that they have in the agency this goes to an agency doesn't it and i have in the agency they have the authority to say we will licenses provided it's made this way but not that way provided you this kind of a check but not that kind of a check they have a lot of power over what is licensed so how can you provide notice by the way means maybe it just means notice that you will commercially market x or maybe it means some combination thereof the reason that i point to that ambiguity which to me is a crucial ambiguity and it has to do with both your arguments indeed all of them on both sides there is an agency here isn't there the f d r s you know we are being asked to interpret very technical provisions that i find somewhat ambiguous and operating in a field i know nothing about but it's going to have huge implications for the future so why isn't the way to go about this case to ask the agency to issue some regulations then when we see their interpretation you all will be able to argue that their interpretation exceeds the statutory delegation and by doing that we would have a better picture well i think your honor to take the text which is where i think the court should look for the answer to this question on page thirty nine a blue brief is the notice of commercial marking for him and it says as you re the sub section k applicant shall provide notice to the reference products sponsor not later than so they're not may go and one hundred eighty days before the day of the first commercial marketing but the one hundred eighty days justice breyer modif the date of first commercial market yeah yeah that's true but of that i have the what what is it you're to provide notice of of the biological product license under subsection k but this statute uses that phrasing to describe the biosimilars that's just what you've just said in answer my question of the license doesn't happen until twelve years plus one well the license can't happen in twelve twelve years west one justice can be but like right now and for years to come the exclusivity period has already run and so when applications are made as it was here we expected to be licensed within ten months of application and were in fact licensed so when sanders gave the notice here and said we expect to be licensed in the first quarter second quarter of next year sandoz was licensed so if the court your questions earlier justice kennedy were getting too does the applicant have an idea how its application is fairing does the applicant know when to expect it's going to get approved the answer to that is yes and congress didn't show any concerns with litigation too early so if your purpose question justice for the purpose of this statute is to allow early resolution passed this buyer's question was about the regulations  well with with respect mr chief justice the united states is here explaining its reading of the statute and agrees with our oddly enough i would i would find an explanation far more convincing as a lay person if in fact there had been notice and comment proceedings before an expert agency which in fact having heard all the different views on what that word notice means and having figured out whether if we allow day one one is that the twelve year x and seventy period was set by the congress and said the f d a can make a license effective at the twelve year point if the federal circuit's reading is right that license is not effective not effective in any case even when there are no patent rights until twelve and a half can i go back to the beginning of justice briar's question he made an assumption that until the approval of the product that the other side won't know exactly what it is that's going to be approved particularly in a situation like this where you you kept your application from the so they don't have so you address that issue in your brief you say they can get it they can get it from the industry from the f c c filings from from  tar all of that stuff but that will tell them exactly what it is that you're intending to market so or the other side how how would you know if you started to clear a tory judgment their action as you're entitled to do wouldn't you know then couldn't you get it in discovery exactly your honor and that's our point so combat's exactly the consequence congress provided when someone failed to provide notice or doesn't provide the application so here sanders didn't provide its application as you know and that allowed to sue that there are two artifacts of artificial infringement created by the statute both of which are key to understanding the whole point which is to allow me to geisha in based on the application if the application just like in hatch waxman that crystallizes the controversy and so in the situation it provides to two acts of infringement and if i can just point them there in each to see of two seventy one so that's on page five and one is in the instance where the parties in gauging the information exchange which applicants are highly incentivized to do if it if there's any fear of any patents that might block your product and apple can't is going to go through the information exchange because it could could the company with the product file a declaratory judgment action when they don't know what you're going to do do they have a good faith basis for believing you're going to infringe if they don't have the application to look at until they get discovery yes you're on so many have ok well first i want to say congress obviously thought they did because it created in the text an artificial infringement for that very thing too and they're right by definition a bio similar is highly similar to the reference products sponsors product so a reference price sponsor would have a good faith basis in that case to bring suit on any pattern that covers its own product or any pattern that covers the use of its own product but it doesn't know the specifics of the bio similar i mean by definition the biosimilars similar it's not identical and whether or not it infringes might have something to do with the ways in which it is different it might your honor but the question is whether or not you have a good faith basis to suit and given the standard of highly similarity and the kinds of similarities there have to be if the sponsor has up any p t that covers its product this product that itself or any uses of the product it would have a good face basis as to which is exactly what i intended here we are suing saying this thing infringes our patent you don't even know what this news you know that the that the appl has submitted to the f d a using your data to produce a product that's highly similar to your product is the way the statute works misdemeanor that if i have a valid patent i sue yes yes exactly does that is that i mean i don't know i'm asking you for just that is the practice that given that these will be similar if i have a valid valid patent i bring litigation right exactly and congress provided for this exact situation in each to see which is on five a of our blue brief made an app someone applying and not providing the application within twenty days made that precise at an act of infringement and you would have a good faith basis to sue as they did here you were not i don't know if i agree with you on that but you would have to sue that's the problem right what would the patent litigation look like i have this patent you're bringing this biosimilars i'm going to sue you the litigation would decide whether the bio similar infringes the pattern and that would have something to do with whether or not it's sufficiently whether it's too similar or whether it's certainly distinct and what your argument means is that if you have the patent justice kagan you have to sue now you know no you are you don't have to say i'm sorry if i misunderstood your question or of practice that that in fact that's the way people operate under this statute that given the similarity of these products if i believe i have a valid patent that the pallet the patent has and lapsed i'm going to bring a suit that is exactly what engine did here and i want to emphasize that in most situations applicants will go through the process because the information application and a copy of the application if it complies with all of the steps in phase one does it stop the bio the the license applicant does provide so does participate in information exchange then they go through a back and forth exchange during that period of time the the l nine a bar and if you like me walk you through it i can explain so but the l nine a bar would bar anybody bring in declaratory action during that well that's assuming good faith and that's the next question which is if you if the bio similar doesn't comply you're saying the other side can sue but what happens if you do comply can the other side and the other side fails to they'd they don't give you the notice that they're required to do something that's required on their well just look at our society if so yes and i but the consequences if they if they come to answer question if the if the sponsor doesn't follow through on the information exchange and then doesn't follow the l six lawsuits so  l stage l six it says the sponsor shall suit within a certain period of time if the sponsor doesn't bring that suit it's limited in any future infringement suit to reasonable royalties that's the provision in e of two seventy one on eight a and i think what this is one whole ecosystem it's complicated to be sure but congress took into account all of these situations the difference there are two  ounce of patent infringement right around one can explain the difference between those two and with respect to justice briar's question you started out by saying all of this so i don't think that will solve the problem i think this is a statutory interpretation question and i think the tax is answered you don't need you don't need explicit regulatory authority there are many situations where you defer to an agency's germination may i go back and answer justice ginsburg's question about the way that the two phases work first your honor there's not always two phases so even if the parties engage in the information exchange it contemplate it gives the sponsor of i mean the applicant a great deal of control the advocate can put all of the patents on the lists into that litigation and if that happens they make they may never be a need for a second litigation if there are never any new patents that's what happened in the appetites case is pending there are no patents left yet apa texas subjected to the one hundred eighty day bar of the notice of commercial marking provision so the purpose of the notice of commercial marketing provision justice ginsburg is that it lifts the gate so once the parties go through the information exchange as a sort of were suggesting that creates a stay of any litigation except for the ones the parties agree to the sponsor has great control over that first of the game the point of the notice is to allow the sponsor to litigate any other patent it might have before the exclusivity period runs out and in the notice does two things those two things it lifts the gate to allow the sponsor to bring any declaratory judgment actions and it also says if appropriate the sponsor may seek injunction but of course if you fall in early enough declaratory judgment action you don't need a clear injunction it's a very powerful remedy that the statute has given to the sponsors mr chief justice i see i am already into my in my into my extra abbado if yes mary's or the time yes thank you the statute expressly establishes a series of procedural steps and then specifies the consequences for both the applicant and the sponsor if they fail to take the steps that would set you off the path and all of those consequences addressed the timing and the scope of patent litigation those consequences which are quite detailed we don't have time to talk about all of them but there in the statute there in our brief  exclusive consequences it would be it would muck up the statute for courts to come in and start policing each step of the l d s and then send the parties back the whole idea of this is  question and my question is the same the f d a is involved in intimately page thirty two of the brief the subsection k application information not later than twenty days after the secretary notifies the applicant that the application has been accepted the applicant shall provide this this this means that the agency gives the notice for twenty days and it seems to me certainly it would be with sensible thing for it to say and we have a regulation if you don't do that and we've told you to do that we're going to delay the review process i actually think it's not so clear if you compare this to the hatch waxman act and i believe you had  opinion called carrick on about that not so long ago that actually embeds the f d a and process of identifying patterns as the orange book this is quite a different process the f d a is involved with the licensure but congress at this point separated or well they've not issued opinions on how this works so i don't know of anything that's inconsistent in any litigation have they taken a different position no not that i know mr yang you indicate that l  remedy to a violation close all right well but you let me know where i get it wrong but or at least i understand that's the primary position of your side but  law and and i didn't take take it that petitioner argue preemption in any way shape or form so where does that leave us with a line might otherwise be the exclusive or almost exclusive mechanism but what happens when we have a claim under state law that no one's argued preempted well i believe santa is argued to pleased in the court of appeals and preempted but putting that to aside the federal circuit in this case deemed the state law claim for the injunction to be moot this is a page twenty four and twenty five of the joint appendix it did so because it found a federal injunction and opposed a federal injunction to enforce the statute that's precisely what the federal circuit made even more clear in the subsequent decision apa text and so where we are now is only on the question of the federal the remedy if there is one for failing to give notice or feeling to comply with the information exchange i will say certainly let them gems positions so i will say that there are very i think there are strong arguments that this would be preempted this is a highly detailed scheme and if states were to start to interject different means of enforcing it in a state by state basis that might be some havoc but we've not taken a position on that exactly when i agree with you but the absence of any argument on preemption is what makes it so curious the judgment below did not rest on the state law claim again if you look at page twenty four and twenty five is where it rests on a federal law it already rests on a federal law cause of action that also might not be there in terms of the preemption question it seems to me that it's very hard to give a comprehensive answer to the questions presented without considering whether well thanks for your opinion on what federal law does but in fact state law you can get the same injunction it's really asking us to put together a puzzle where a big pieces missing i don't think state laws a piece of the puzzle congress does not have the habit of an act in comprehensive statutes and then allowing states to fill it figure out whether becomes part so are you arguing the preemption quelling or we think that there are strong arguments again we've not taken oh no you didn't give sufficient information didn't do that you'd have a series of back and forth in the scheme the whole idea is you go along a path and at certain points if you don't do something you bump out you're in litigation so you end asking us and there is no federal injunction that's possible here with a cane and remain and for the court below to decide whether state law you know i think the best way for the court to decide is what's required under the statute because of action if you do that you leave open questions of state law and preemption the cleanest way is just to resolve what the statute stars and i see the statute we say the statute says that if the start what are we doing we're saying the state law is moot no because there's no state law claim if you're complying with the federal statute there is no state law point the state would be back on federal law i also want to address the question that the court had earlier about know what you know and you have to know what's licensed in order to identify your claims if that's not preempted how would it it would just fail just like on l two the federal circuit said you're complying with federal law therefore you have a new state law claim because your state law claim is predicated on by a ling federal law it would be the same for both so the reason it takes the question on the question we're not looking at begs the question on point on the first point which is is it a requirement that the bio similar athlete can't give over the application are complying with the statute is the mandatory condition precedent to continue on the path to take all of these steps but if you don't and the statute provides an off ramp you're not violating the statute congress comp contemplated that power now on the question of licensure remember you have to identify at the very beginning of what all the patents are at the l three stage one of the consequences is if the sponsor fails to identify the patents on the list the sponsor can never bring an infringement action period this is t seventy one eat to so you see a and b and so the the consequence is that if you get at the ending or like oh something is new something i didn't think about use you have and so all they have to do is number one day one they give the section to notice and of all the information on day two they give the commercial notice and all of a sudden everybody is free to do declaratory judgment that's right and that's what it's supposed to be that's what it's supposed to time that was deposed to set up a system where you put tremendous incentives on people to negotiate and to work it out in an orderly way that you can just got it by simply filing your commercial notice on day two there are strong incentives for instance if the applicant doesn't give the information and to be in the forefront the l to information the applicant is for his bar know he'll give it he'll give it well if he gives the information then the legal carry terry courts come in and everybody jumps in on day two that me this would work out a lot better if you could somehow get this to in rule making thank you counsel oxman mr chief justice and may please the court congress did not create detailed procedures for resolving biosimilars disputes and repeatedly used the word shall merely to have applicants who choose to take advantage of the statutes benefits and use of the sponsors information then disregard those mandates i think i think i'd be inclined to be guided on what of which of the many complicated aspects of the statute to talk about by the courts by the courts questions it's tempting to sit to just stand up and give a tutorial on this extremely complicated situation  wouldn't that stop face to litigation from starting immediately by your definition they could go involved disputes about other patents not the ones that they now and so wouldn't your reading always force round to into the post slices twelve year period i thought the whole kircus of the statute was to get round on it around to be done and done before the twelve year period is finished you know the whole the purpose of the statute assuming that it's followed that is that there that two way is complied with and the information exchange occurs is to have all patent litigation concluded before commercial  launch should be twelve plus one so you want to have an exclusive license for twelve years so let me address that the twelve years plus six months first and then go to the point of why the notice of commercial licensing hasd two can only coherently be done once the f d a has announced what molecule has been approved for what therapeutic uses and by what manufacturing processes which is the of paramount importance when you're talking about biosimilars so as to the hundred eighty did the twelve versus twelve in a years and the f d a no one has yet applied for bio similar liason sure until long after the twelve years has ended so we don't know when the f d a how the f d a will address a license application that is made during the twelve year period but two panels of the federal circuit have read the language of the statute that says and this is two sixty case seven that f d a approval of a bio similar may not be made affective until twelve years until twelve years of data exclusivity has run two panels of the federal circuit have said that only means made effective the f d a certainly could adjudicate a license and grant a license effective twelve years after you know the exclusivity period is my argument well because if the f d a is taking that position then it's basically kicking off the possibility of around pretty early yes now that as as as my friend on the other side pointed out the notion that there is going to be round to litigation very early in any event is unlikely for the following reasons number one as they've reported it takes about ten years even for a bio similar to get developed and you know amgen is both a reference product maker and a bio similar maker and that's in fact consistent with our experience so the notion that there's going to be you know an application filed in year four or year six or year eight is unlikely another reason that it's unlikely is these molecules these biosimilars you know up until  very very recent advances in gene sequencing biosimilars were the way they were defined was by the process under which they were made you take a particular cell line and then you do the following eighteen things at this atmosphere of pressure and the f d a will not approve a bio similar until it has inspected the manufacturing process and facilities which according to the record take is about one hundred or two hundred million dollars and the notion that a bio similar is going to create a whole factory for the f d a to review and then leave it open for until year twelve is quite unlikely but the issue here even if the f d a took the position that nope even though the statute only says that approval can't be made effective we're not even going to tip our hand until twelve years is over it still wouldn't defeat the manifest purpose of the statute this statute like the hatch waxman act has to relevant period so there is a period of data exclusivity that is the period in which a competitor can't use the sponsors data that's not a period of market exclusivity in fact there is a competitor to the product at issue in this case that's been on the market for five years because  actually approves and then the thirty month period for patent litigation occurs where as here the f d a approval when leave aside the question of when they can or can approve it if they don't approve it until some time after the twelve years has run there's an additional hundred eighty days we don't know that because this is never happened but even if it did the reason why congress the reason why you have chemical synthesis so there's no question when and when a generic asks for hatch waxman approval we know precisely what the molecule is we know precisely for what therapeutic purposes it will be used because it has to be identical and no one cares what the manufacturing process is because this is simply chemical synthesis of an identical molecule whereas and this goes to just as briers question about notice until the a decides what it is what is the compound that it is going to authorize which by definition won't be identical and until it decides for what therapeutic purposes that will be used and until it specifies what the manufacturing process in what location will be approved you can't give notice of anything and in and fact if you look again we're on the hundred eighty day notice provision subsection a of two sixty two they'll say which i'm sorry i'm i'm looking at my own appendix but it's on the most important consequence of eight a and this does go again i think justice sotomayor with respect to your question about how soon this can be done that a day notice first and foremost allows the sponsor for the very first time to seek a preliminary injunction against the commercial marketing of the product for the uses using the process and you can not go to a federal district court and ask for a preliminary injunction until you know a that there's an imminent see that occurs you can't go years in advance b you have to know what it is that you are seeking to enjoin this notion that there is some artificial act of infringement that relates to whatever you may or may not know is in the original  application for article three purposes is irrelevant i mean once the f d a that the question is can you get an injunction against what is approved for what purpose is using what processes until you know that a court doesn't have a way of to be able to evaluate it because you know in the seven years that this act has been in place the f d a has accepted for review only fourteen of these applications and has only granted five of them  last one being last friday and so in some of them there have you know that for example we amgen got approved by a similar approval for its bio similar to the reference drug q mera we got that last year we haven't given the hundred eighty day notice yet and so we haven't started commercial marketing and it could be because some often the bio similar w wait until the expiration of the regular relevant patents it also can be that there is this this litigation occurs phase one phase two or whatever and that there is they then a settlement which is in fact what happened between am gen's reference product in this case and tev a as a competitor we there was there was litigation and the litigation was settled so but that the point here and if i can just maybe this this this is that is a good point to shift to the l two a issue which is the requirement that you provide that once the buy it once the applicant decides not to go the regular route that is the a route that is to to do all the testing and prove that this is safe potent and pure but instead to piggyback on to the reference products once that's done the statute says not only into ebay but also in one ebay says that you must once you make that choice the consequence the consequence of using the reference product sponsors data is if i can just quote one big quote when a subsection k applicant submits an application under subsection k such applicant nine nine nine c rather well nancy what the remedy is and we've heard from the other side that the exclusive remedy is the declaratory judgment action and how can we possibly decide what to a means without taking a peek at nine c as to what remedies are permitted well what i mean we agree with the government that went to a says shall and when one b says shall that is  to this question just want to make sure that i can't it's hard to force a right from its remedy isn't it and to understand the contours of the right to a gives you a certain right to information we don't usually understand the right make context of the remedy provided and  so let me can i bookmarked the state law cause of action because i do want to get back and explain why our best to our ok let me do state law first which is what was at issue and was adjudicated here and then go to the federal law issue so the litigation the complaint in this case asked for an order under the california statute the california statute like many other states statutes including the one that was when i got that ok i'm sorry my question is how can we understand what a violation is of federal law without looking at both the right section and the remedy section well because the violation is circumscribed in a certain way here by the realms provided by federal law so i don't think this may be a definitional failure of communication but shall either means shall the remedy question is who can who if anybody can do anything about it if you don't comply with shall that's no it's not quite that sound is if you want to info this federal process this is what you have to do ok right so if you don't in the print federal process what remains that's not a remedy that's a different federal process judgment process that's what ceases under your reading become superfluid because if you can get a state information exchange provision c or under state law why give the remedy of starting to clara tory judgement action ok all right so let me go right to section nine i'm not trying to avoid it section you have to look what section nine says nine see is if you will an exception or a clarification of nine the background principle is that congress has established an artificial act infringement which is the submission of the a b l a submission of the bio similar application that is actionable there is a federal cause of action under section any time you want so long as there is a level of immediacy which by definition there is if an artificial act of infringement has already occurred now what nine eggs says is not withstanding those back around rules if the bio similar applicant shoes is the case and provides the application and the manufacturing information we're making an exception to the general availability of declaratory judgment no one can file a declaratory judgment action until the notice of commercial marketing is given what nine cs simply does is it has nine c says if you don't provide that to a information you the applicant can't ever file for a declaratory judgment action but nine c doesn't remedy the sponsors harm for two reasons number one it has no real operative effect with respect to the sponsor because recall what not nine and a the nine a limitation is implicated as the first clause indicates only it in those circumstances in which the application and the manufacturing information is provided i would nine c simply confirms what is what should be obvious which is if it isn't provided the sponsor is left to his background rights means shout ok but let's stop there because first the federal part which i just read doesn't say with that's the only remedy or that there are others but even if it did we wouldn't know whether california law picked up just the substantive part or the substantive plus the remedy and even if we knew that we wouldn't know whether some other state would be free to pick up in their own state laws shall but not exclusively as to remedy and those involved either preemption questions or questions of interpretation of state law and none of that is briefed and therefore we stop shall means show how do you like that but still i like shell means shell i still want to get back to to make the ninth see point but let me address your state law question first we know without state law federal remedies it says it is a violation of our state law fair commercial practices law to violate a command of another sovereign well not only that i mean if we apply california law then presumably in some circumstances we apply the laws of every other state and maybe they reach different consequences and if as your friends on the other side are right that there is no federal cause of action for this type of  relief then it seems odd to say but there's going to be you get the same thing under state law well let me let me address that head on out to this judge the issues first of all the preemption question there's no ambiguity about whether preemption was waived at page twenty six a oh no i understand that but i'm not going to interpret a federal statute based on the decisions of one party to waive the argument or not i i completely understand that in debates versus  science the court rejected my argument that the the farmer in question had a remedy under i believe it was texas state law for the violation of a substantive caliph texas state law made a violation of state law a violation of a substantive provision of the federal fifth for a statute and i argued in that case for the defendant that congress had considered what remedies if any to provide to individual farmers and had made and adverting to seize and not to provide any this court pretty emphatically rejected my argument and said that because texas had made it a violation of texas law to fail to comply with a provision of the federal fifth floor the plaintiffs could get a remedy available under texas law now here i mean the there's nothing really i mean i agree that we you know it's somehow unsatisfying to say well the only the injunction that was sought the order that we went in to say look you have to order them to give us this manufacturing information and to give us notice at a time when it's coherent to talk about notice about what and we the only remedy that the california statute provides is injunctive relief  doesn't allow for damages at all and we're entitled to this we're a california company they're violating our laws i understand that it's on satisfactory and that ultimately some day perhaps this court will have to decide whether it's whether  federal enforcement even if state law didn't exist at all though i do want to suggest that if this court says look shell means shell and you must if you if you choose to parachute onto the back of their information you have to at least let them know that you're doing it and what you're doing and in order to give them notice in time for an order to really this would end up under your theory forcing a bio similar to in phase one because at every stage you wear this choose to opt out they just run to court and say my state law remedy is force them to take the next that you need the application then identify then do this you're going to there's no longer a choice so justice sotomayor two points number one in terms of should all this shouldn't all this patent litigation be done early and often everybody understands that the applicant the bio similar application under the phase one phase two process alone decides which patents and issue in the exchange of lists are going to be adjudicated the pap the applicant announces the applicant can say to the sponsor in phase one we're going to all of the patents that are on the third of the l three lists the only qualification is if the sponsor if the applicant says i'm not going to i don't want to litigate any of these things now i want to wait and see what's approved th sponsor has the election of choosing one patent presumably the patent on the molecule itself to adjudicate so the it is in the applicant's hands to get all of this litigation on artificial acts of state law can force them so you use seeking injunctions to participate unwillingly ok let me let me go back to nine which i think is the source of sandoz argument that the statute already provides remedies for the two violations that we allege occurred here and if i may let me let me address the two substantive provisions differently because they say that nine d is the remedy for a violation of the hundred eighty day notice and nine see is a remedy for the violation of not providing the information the notion that nine b a remedy for the failure to provide one hundred eighty day notice is is crazy the hundred what eight days says is you can't file a declaratory judgment action until you get the notice and what they say is well but the remedy of not giving notice is that you can file a declaratory judgment action and not only that you can file a declaratory judgment action and you must file a tourist or a judgment action at a time when you don't know when if ever the f d a will approve what it will approve or for what purposes and by what means and if there is a violation of the hundred eighty day notice period the first time that see the sponsor is going to know about it is when the f d a approved and what's wrong with that why can't you argue that the notice is defective and seek its were judged on the basis for the notice is insufficient doesn't provide you with adequate notice it's required by statute well that of course is exactly what we claimed they gave they purported to give us notice the day after they filed their application we said that's not valid that's not the right time the question i'm separating out the substantive question of when notice has to be given i understand the end of the exam is if you say the notice itself is defective apart from one it's given because it doesn't provide enough information isn't that a possible remedy right there well yes in an instance in which that the notice simply says we are going to begin commercial marketing in one hundred eighty days no less than one hundred eighty days our you know the issue in this case is the substantive issue will leave aside the enforcement question is that's not notice it in order to notice something you can't provide notice of something when you don't even know what's going to happen that is notice ordinarily and for that matter logically implies that the preconditions that are outside your control have been satisfied if i say this notice early tells you what it tells you i filed an application and if they approve my application i intend to start marketing immediately i don't know whether they will approve my application i don't know if they approve it whether they will change the substance whether they will change the indications that isn't that true of a lot of what this act contemplates i mean all the round one litigation can occur before the approval is given that's right and that's the reason why you have to have that's why a a pass to the notice hasta for com at a time when we know what it is that's approved that is the parties may choose but i guess what i'm saying is that it seems as though the statute contemplates that you can do a lot of this process prior to the approval but that's not a necessary piece of information you need in order to start evaluating whether there's infringement so justice kagan the let's say phase one starts i mean i i think i probably ought to talk about what happens there are there remedy for not providing the l two information at all but let's say the parties decide ok we've we've each listed all of these patents that are potentially applicable that list is coherent if the sponsor knows what the application and what manufacturing processes are therefore if we don't know that we have to list every patent that we have on every manufacturing process that we own which is incoherent but let's assume that the parties say ok here's a list of patents how many does it make sense for us to adjudicate now it certainly makes sense for us to judy judy kate the patents on the molecule and perhaps the purposes of the molecule it may be we think it makes sense to get a court to adjudicate all of them but even in that instance number one under else the statute and l seven recognizes that the sponsor may well obtain other patents after the lists are exchanged that has happened in this case and in the the texas case that that my friend was addressing where they said there are no other patents available it is about to happen in that case too because that the p t o has just allowed claims that read on that pat process the sponsor gets a mandatory injunction under two seventy one the fore and in any event if it turns out that what the f d a has said is well you know there's been a lot of it we acquire lots and lots of amendments to the application in this case they were quite there were thirty amendments made from the time the application was filed until it was granted if it turns out that when the f d a issues its license it license something materially different than what the application was the parties and and the district court have to have some opportunity to say wait a minute i mean we adjudicated patent infringement on the assumption that the manufacturing process would be x y and z but the f d a didn't approve it they insisted on a b and c and there has to be some period and that's what the hundred eighty days does to allow the parties to say even with respect to the phase one patents we now have a real dispute the f d a has approved something different than what the application was and the the  sponsor has to be given some period of time in order to figure out what the f d a has approved and a district judge has to be given some period of time to evaluate like what are these patents what is this compound what are the court has decided one of two things there is a patent infringement it's issued an injunction the f d a has narrowed the scope of things substantially if the applicant was seeking the world and the f d a is the one who narrative why isn't that fair to the licensed product h to let that injunction continue until there's now certainty that there isn't if he if the patent infringement process ended up saying no infringement desser court agreement and there's no injunction so no least licensed products is going to deal with the goods in the market but they've got a shot very we've not had a situation and it is remarkably on likely that we will get to a situation in which there are no patent disputes left to be resolved once the license issues both because as has happened with respect to our product that issue in this case and in the apa text case the f d a the p t o has indeed issued a patent that bears on this that we couldn't include in the lists number two everybody needs some time to be able to figure out whether your hypothesis is right which is that what the f d a has approved is narrower than what the application was not broader and all that the hundred eighty day period does is give oss the reference product sponsor an opportunity to figure that out i mean we have to the eight c requires the parties to cooperate and expedite discovery once the preliminary injunction is filed so that we can figure out for example what manufacturing process is the f d a has approved that's not made public at the time that they approve the license thank you and also a three minutes there can be no doubt that the judgment that we've petition on is a federal judgment that the federal circuit issued a federal injunction and dismissed their state law claims to that the statute congress when it wanted to provide for injuncti relief of the procedures it did so it provided for in only one instance violations of the confidentiality provisions in l one age and significantly that's also the only provision that congress called a failure to do something  the violation wants you to read this statute and to read those the rest of the provisions as implicitly entitling them to an injunction that congress chose not to provide and instead they want to call the remedies congress did provide as the backup i that's a very odd way to read the statute the rights here are patent rights the remains they were given were and remains and there forceful they gave them artificial infringement actions in the case where you participated in huge change and the case where you don't congress shows no concern in the notice of commercial marketing provision with notice being too early it says at least one hundred eighty days and when you lift the gate it allows the to sponsor to go to court and litigate any remaining patent rights they have justice prior the congress knew how to require something to come after one a vent and before another it does it in the very next provision eight b does not do it in the notice provision you shouldn't read that requirement into the word licensed which is just a description of the bios similar congress would not have extended the twelve year exclusivity period in such a bizarre way that was a very hotly debated item and it would extend the ex vity period in every case even when there are no patent rights to litigate our approach fully allows them to vindicate their patent rights we wrote them and we told them to sue us now they delayed but they could have sued us right away that was the added they they were issued new patent during the suit they have added that patent to the suit which is also common in patent litigation a lot of what they are telling you blinks reality about the way the world works and with respect those kinds of policy arguments are for the congress this statute works if you just apply it according to its terms the shall conditions are all conditions precedent and that's made clear by the l six provision which says they shall soon it would be a very odd federal law to say that is a violation of federal law not to bring suit it isn't congress right of consequences if they decide not to sue then they can only get a reasonable royalty these are these are shells and they do mean must but the government says they don't mean must in all circumstances they mean must if you want to continue in this process and if you don't continue in the process there are benefits and burdens to both the applicant and the sponsor at every step and if you go through the statute and i recognize it's a very to kill a good scheme it's all one coherent whole and it gives them a very powerful remedy thank you counsel cases submitted