the decision of the district court should be reversed because it can play to the issue of subject matter jurisdiction with a premature analysis of the merits of the plan the district court had the power to decide and here are the issues the question of whether  i beg to differ that would assume that the simple filing of a section eight statement would immunize the generic from a lawsuit and basically you serve the federal courts from what we are saying is that there are two separate provisions you have the certification provisions from the food drug and cosmetic act which govern whether the generic will certify and for method of use patent under  paragraph four or under section eight we're saying irrespective of which certification provision you have we still can bring a lawsuit under to seventy one eat two court held that the use of which is claimed in a patent has to be f d a approved uses they have attempted to excise out the patented indication but we know from this they they have excised out the specific patented indication but that does not mean that we still do not that we still believe that the use is listed in there and will still induce infringement of our f d a approved method of use perhaps if they're not asking for whatever they do later you can sue them later on the two seventy one hey you're not under warner lambert to say to be uses that are f d a approved in the whole intent of that decision in warner lambert was that it was a legal in possibility for the generic to seek approval of a we're saying that they are seeking approval for the uses which are claimed in our patent but that's directly contrary to their application that's that's looking at the core of the alley and what you think will happen galba line x post but it's not looking w their application and those that we're entitled to prove because just as this court held in astra zeneca the app attacks where there was an attempt to excise out the patented once a day  nevertheless there was still enough evidence in the label and elsewhere to support and evidence of a likely induced infringement and that is exactly the situation we have here we can't you cannot the bizarre language on the one indication which it says wink wink look at astra zeneca it's label and and we can't seek approval because of their marketing exclusivity but those are facts that we would like to prove that we were denied the ability to prove based on a subject matter jurisdiction analysis in the lower court we are just simply here to see our day in court which we were denied based on a rule twelve b one  and the court went on to to address the validity of our claim when we didn't even have the ability to prove barker if you get past twelve b one b you still have two of the six problems we don't we to file section eight statements thinking they would be immunized from suit which would unilaterally give them the ability to determine at the outset whether or not the that's exactly my point your honor that's exactly the point and that's exactly proves that we would like to be able to prove in the lower court is that we believe that irrespective of the attempt to carve out a patented indication nevertheless doctors can and will prescribe that there that generic drug for the very same uses that the branded drug is is indicated we can use right the but that defeats the whole purpose of the hatch  arguments on why it might be beneficial to allow it but i just don't see how we get around the clear language that congress only carved out access to the courts in advance in the in the process when they are actually applying for the use in your pat not believe that you can read the limitations of the food program cosmetic act notification provisions into the plain language of the statute that the language of that statute does not say that if you  section eight statement in your core about the patent it indication that you don't have a cause of action it know it as you only do have a cause of action when they're applying for the use you have happened and we are submitting that they are not applying for the uses distinction it's a question of happened but it's not them applying for those uses and that's all that's allowed her to seventy one be to create a special cause of action it's a question of how you interpret the language the use of which it's claimed we are submitting what they've asked for in there in the will induce imprint of our method of use patents and that's what we would like to prove back as we didn't we weren't entitled to prove those facts and what we're saying here is based on the facts that we have here because the patented indications are related and so overlap in your respective if they try to carve out the one single patented indication that they use is listed in there and a will nevertheless induce infringement of our method of use two seventy one hundred two in this court's precedent more lambert and secondly it's not a jurisdiction if you listen your honor i don't think it matters i think that either there isn't subject matter jurisdiction or a claim hasn't been state statute provides for a cause of action are you referring to after the fact when when when the company or market are you referring to to the jurisdiction or to seventy one  the to the court decided no jurisdiction here right correct you defend that ground i do are we do on the grounds to be in two cases one that the claims are not right based upon the allegations that they've made secondly to seventy one of the two was created for the purpose of conferring jurisdiction in a situation where jurisdiction won't otherwise exist it establishes a case or controversy and cause a pat stiction you have to both invoke a federal statute and state a claim upon which relief community what they have alleged here and what the conduct that the a pelleas have done what they seek approval for just doesn't use and it looked at the plain language of the statute and said in the statute values means the use for which the and the applicant is seeking approval and the language of patent in the statute means which they defined as uses for which the end applicant was seeking approval just to help me out here with what's going on and in your world why would you do this because if you put your drug out there under these limited uses there's at least a substantial likelihood that there will be induced cite back to this proceeding as evidence that you knew of the risk and undertook then you're going to willfulness as well as an infringement on help me out with your strategy here  reason the reason why the generics do this is because it's permitted under section eight congress clearly made the policy and that you wouldn't just do everything this permitted if it's going to hurt your business i'm trying to figure out but isn't a single the the bottom line though is the law of inducement generics don't promote drugs they sell drugs they don't promote them for uses other than what's in their label their labels the only point where it says so you think you can when the inducement case inducement requires this that absolutely correct that that's a that's the way that the generic market works and therefore it's generics are not going to induce infringement later in time but it to their point is they put bring out this situation that it's going to happen and we'll have no no cause of action well there is a if it does happen if the generics do actively encourage infringement there's a two seventy one a and b case that they can bring and if that's different than it has been if they find in your f precedent in well warner lambert specifically addressed this issue then we have d s you and we have vita makes that all address the very issues that you need to have a specific intent in the act of encouraging mere knowledge that somebody else is using your product infringing going to use it for pediatric use even though i tell you no don't use a pediatric use wink wink you're a girl well this is the mean this is a this is a two seventy one b situation so that's not what's happening here so i don't know what all those facts are all the facts that a approval for the use claimed in the patent suit and section eight describes actually the opposite conduct it says when you're not seeking f d a approval for the use of a patent tell us that rightness issue over to the rightness issue as i understand it the the there complaints and the f d a will require the label like you'd like to include information relating to the used to treat pediatric patients has the f d a placed such a requirement on ya know i know what it would and that was shown we disclosed in the motion to dismiss the tentative approvals from the f d a which means that everything is ok with your whole anda but for an outstanding patent issue which in this case was the three one for patent from previous litigation we submitted section eight statements that said we are not seeking approval for the uses in the six one eight one five two patent and we showed our labels in those instances the there was in the patents listed in the orange book and that in the current regulation three fourteen point fifty three says that only list of approved patents in the article so we're always dealing with approved uses section eight is always criminal sanctions for approving for those uses that's f d a law but that's what it is that it would be illegal to do that  i finally i guess that to decide dress the point that the appellants are asking for discovery there's no discovery that can change what what the facts are here we're not seeking approval for the uses no amount of discovery can change that the fact that something might happen in the future that's to be addressed in the future for labels required to be changed then maybe there's an ied to action if we have to include indications for for the six one eight one five two patents if we actually market first press i think one of the issues that was raised subject matter jurisdiction is a separate inquiry from the state a claim that's quite clear from the governing rules not rule twelve the one where you can state it at any point in time and under twelve these six you have to evolution before an answer is been filed and in fact the whole issue here is the court did have jurisdiction and in fact it almost it understand there that the issue there was the end as a whole was likely to induce infringement the in that situation it's a classic example where there was a section a carve out that was approved by the f d a that indeed led to a finding that there was evidence elsewhere in the label and other evidence that they are in fact would be induced infringement just as paragraph or certifications can be in error section eight statements can be in error and the innovator companies should be have a venue to do that the correctness or incorrectness of the state to state otherwise would allow the generic to simply file section eight statements after section eight statements avoid the thirty months to avoid a lawsuit and thereby deprive the and in some instances that may be true well let me back up a second and then they they are they way they would not get approval for that specific patented indication that is true but that doesn't answer the day the question as to whether the uses that they have listed in there and at the end of the day would nevertheless still induce infringement in terms of the discovery that we would see we don't even have all of the labels yet we would see to see what the generics are doing in terms of their therapeutic equivalent substitutability request because in fact what truly is going to happen in the marketplace is they are going to those generic drugs will be substituted freely by doctors and pharmacists for the very same indications for which the brand drug will will be prescribed and indeed the last piece of evidence would be to look at their market projections because i guarantee you that none of the jet generics have carved out these indications when they're predicting their level of sales but that i see my time is up thank you thank you very much that c