please the court congress and acted hatch waxman counter claims to address the problem of improperly listed patents that was identified by this court in the modern decision in this referenced drug that is sufficient your honour's to resolve this appeal the counter claim is not available because the patent is properly listed like you change your use code two thousand and nine you're on it there are three reasons for a change  require you are not required your honor but this company's practice in fact most branded companies practice is to tie the use codes to the indications the regulations allow that the form calls for that and f d a is practices bennett in fact before two thousand and three when f d a itself wrote the use code for the first one thousand years of the statute f d a routinely based used codes on the indications and the reason for that is simple section eight this is section eight carve out case is premised on the indication if you go back to the original one thousand nine hundred four statute the examples given by congress explained in great length by this court in the one or lambert case what congress says that section eight is there to carve out a unclaimed indication here on our first there was a there was a nine or ten month delay back and forth with the agency before the new label was proof of the new red label wasn't approved until july two thousand and eight the directive was in november of two thousand and seven and again this is a heavily regulated industry with continue dialogue both oral and written with the agency it was a significantly lengthy process for the for the new label to be approved there then was the ongoing and application with multiple amendments i believe character was on its fifth or progressive disease with progressive treat diabetes patients who start out model therapy either metformin or peg and i routinely almost uniformly end up with some form of combination therapy and the metformin combination is by far the in the orange book the f d a publishes a large number of information he probably doesn't really method of it including use codes and including other information called for by its regulations informal talks so the secretary doesn't just limit themsel pack number and expiration date when he's directed by the statute to publish information under b and c he has construed that his covering the method of use information i disagree with that to this extent here under subsection five zero five b one directs the secretary to publish shall publish information submitted under the preceding two sentences that is a number of expiration date the secretary is then exercised his general rule for general under section seven a one statute to require additional information if you look at form three five four two it calls for all kinds of things such as wala nevermind the fact that the secretary publishes information other than expiration date goal here is to put generic challengers on notice that there is a patent that's implicated it is not to describe the patent or to go into the details about that is left in a paragraph or case for judicial determination or one of these other cases for f determination and one of the problems in this case with that with the district court's rulings is it confuses the notice function of the statute of regulatory regime which f d a has been very very clear about with some other issues and and that's not the congress and acting in the counterclaim that's not congress provide a remedy for congress again said unless you can prove it was you the generic competitor can prove that this patent was improperly listed then you have no co claims a method of yours not a true method but any number i think that's responsible use the approved method of means approved in some other application yes you're right but what why should one construe that to mean approved in this about a yes read said the drug for which the application was approved in that core the the application with the application not some other application right your honor is the n g a folders the particular application you're saying b b means any application your honor the particular application is the application on which the listing is based in which it's a cross reference back to section five of five so that if there is a proper five or five this tick which is any pursuant to an n d a approved by f d a that includes this method of using the drug there is no other application issue in this case write only one application so i thought that's what the application means in a correct or a right so but prepared for treating diabetes standing alone it only did it in combination that's correct your honor it is a combination patent and it is a common and approved combination that the chemical certainly isn't limited to north listing requirements to single therapy drugs or or single use products that this is a this application was approved in the patent was listed because both the drug and the combination are listed met on it in a list for why why should we read b b when it says approved s how do we know that congress didn't intend to criticise the result that the language read literally requires denying you a chance to make up a paragraph or amendment forcing you to make a paragraph or certification and prove non infringement and thus preventing a generic from going on the market knowing that its drug is going to be used for a patented purpose because you're on to read the statute as a whole not just this provision in isolation of the statute as a whole and i suggest that you read section eight and if you can turn to section eight the reason it's important is because you're not answering my question my question a language seems to compel exactly the result no more nor disk has just required here is a method of using the drug therefore you're denied the counter claim which means you have to use a paragraph for certification and if you use the paragraph and you have to prove non of cringe meant which prevents you from just putting your drug out there and enjoying the fact that it may be used for patented purposes as well as the un patent purposes the answer to your questions and section of the statute seen if you can you have to come to grips with the language of the stand you know bade suggestions that it would be a good idea to do this or implication you've got it you've got to deal with the language or the fancy and so what the question is what is you  the counterclaim provision and this is how a language to section it which deals with precisely this situation where there are multiple approved use some of which are patented some of which are not here's what section  for a method of use patent which does not claim aids in the singular for which the applicant you seeking approval this deals with this very circumstance there are three approved uses found in the crowd there are three approved uses for  method it does play one improvement the drug but just like section eight it doesn't say anywhere in this language however if there are other methods not claimed then refer to section eight does it it right back to the point how do we know that the deal and believe me we're aware that there are complex deals and negotiations over this how do we know that the deal whatever that it was not claim an approved use of using the drug here interest clearly does not claim to approve the uses of using the drug which gives us the right in such a neutral manner label no one was reading an approved method as any approved method there are changing the language to question in the use of the word group here is whether it's a it's referring to all three of the methods in the original india or whether it's it's focusing on the single use which is reflected in the end which is i think i would sit a little bit differently just by thinking abit when it says the question is whether the patent does not claim an approved use it's asking the same question section eight asks whether the application does not claim a single approved use the same question in both statute and the answer to the two statutes is to provision should be construed similarly let me make couple of additional points on this it really all depends on context really off the shelf and they said that's exactly correct what depends on the context but what if i said to you your honor i know when you've got a negative it changes the and me it's the negative that makes the conversion and less paid too much money in taxes because i did not claim an exemption would you understand to say that means that he could claim i didn't claim any exemption i don't think so i think you would understand i didn't claim a particular exemption they could have saved me some money statute is construed in the same way you have a counter clinton to correct or do you meet patent information the patent does not claim an approved method and that's the situation we have here the patent does not  prove i'm still struggling with the idea that there is there is a way for me to justify all this under the policy that there is an apprehension that it generic can go on the market and then of course once on the market to be used for its patented purpose and so there is the policy of forcing you ended  paragraph or which forces you to show that you will make every effort to avoid any and cringing use i don't think it would i can see a logical way that congress would have we don't advertise we have a label that instruct you very happy to take that twenty five percent of the market once you're generics on the market and dice court's precedent we wouldn't be infringing if we did so as long as our indication was completely silent on that issue the fact of the matter is if you use our product any number of them but it could be that congress says that we want to address in the hatch waxman context by making you go the extra step of showing that you will not be used in an imprinting matter nobody in this courtroom suggests that with our amended label we will infringe this p off the market unfairly in the rational world when there is no allegation that we infringe this patent should we be kept off the mark until two thousand and let's accept that is as an accurate statement whether it is or not that's accepted then that the listing for the other commitments isn't proper because they're not going by the path and they shouldn't be listed in the orange right and what you're essentially saying is that the listing  to stand me but but that's the idea is that it doesn't it when it says an improvement if you use it means an approved method of use which could properly be listed in the orange book that's right i believe that i believe that that's correct two points  within the next party and that's exactly what i want to address your on because that argument to reserve the word correct back into the statute does not withstand even mild scrutiny here's why for two reasons one is why would there ever be a need to create a federal possible action ok to correct an innocent mistake which is what they're suggesting would have happened there would never be a need to create a cause of action for that number one number two why would the generic  may have happened during the regulatory period so the expiration date can be changing throughout the life of the patent and there may be a need to correct it when they're in that certain circumstance and that you couldn't do that it was eighteen bill east on an improper use code and what he said is the idea of this kind of claims to close loopholes in the wall to any abusive practices in the pharmaceutical industry by permitting quote a counterclaim to correct the patent information in the the statute defines patent information well that's not true there's a definition section in it does not define patent information in context when it refers to patent information in the statute it doesn't just refer to the patent number and the expiration date it also refers to publishing patent information which we've known since how long this information is all been published in the art book including patent you suppose it's not a reasonable argument they're making moreover in june of two thousand and three six months before the counterclaim provision was an brand companies would be free to submit used codes that were divorced from the method of use patent stuff and they would be able to submit overgeneralized codes that effectively write section eight out of the statute completely read out of the statute because every time that if this court issues an opinion allowing this to happen that means use codes will be really broadly written and section eight will become a no they are arguing with the f d a decision to use the use code as a proxy for the section eight carve out that is probably a challengable decision but it's not challengeable in this court there really is an a p a making authority under section seven zero one it was never purported to be an interpretation of patent information under b or c which is the language that is used thirteen times in section five zero five and if they're going to change it for this purpose they would have to change that drug these uses are all approved one of them is patented and again congress always understood the carve outs and the uses as indications indication means in the regulations treatment of a disease that  parked out and limited to the one method of use the not covered by the you know your honor that's a determination that it is not and again look at mylan mylan said a patent a generic cannot challenge the listing of a at the paragraph or situation they say we shouldn't be here at all we shouldn't be a defendant in this infringement suit because your passion never been listed congress gave the courts the opportunity to make a binary determination off which is the patent properly in the orange book or not it's probably want to book there's no thousand pages of actual legislative history that refers to this it's a delisting statute because this patent is properly listed as they can see there is no counterclaim available the simple should proceed under paragraph four for the rest of the